What Product Can Affect the Permeability of Gloves
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Abstruse
Disinfectants may cause agin furnishings straight on the pare or systemically by permeating through the peel. In this study breakthrough times were measured for surgical gloves with chemicals which are commonly used in healthcare. Classical methods of analytical chemistry were tailored for the permeation tests, which were carried out co-ordinate to the European standard EN 374 and the American standard ASTM F739. An exception to the EN 374 standard was made past using a 4 h testing fourth dimension instead of eight h. The gloves did non showroom permeation of potassium hydroxide (45%), sodium hypochlorite (xiii%) or hydrogen peroxide (xxx%). Furthermore, neither glutaraldehyde (ii%) nor chlorhexidine digluconate (4%) in the commercial disinfectant solutions studied exhibited permeation. Slight permeation of peracetic acid (0.35%) and acetic acid (four%) from a disinfectant agent was observed through single layered natural safe materials. Clear evidence of formaldehyde permeation was detected through single layered natural rubber gloves, where the ASTM quantum times were 17–67 min, simply the permeation rates were not high plenty for breakthrough to have occurred according to the EN standard. The gloves in this study which offered most protection from chemical permeation were the chloroprene gloves and the thick double layered natural safety gloves.
Received 1 July 2002; in final form 17 December 2002
INTRODUCTION
Gloves are used in healthcare mainly to prevent the spread of infectious diseases (Rabussay and Korniewicz, 1997), but their use is too important for protection against hazardous chemicals. Gloves were showtime used in surgery in 1889 later a nurse had developed an allergy to a disinfectant used during surgical procedures (Burman and Fryklund, 1994). At nowadays, the protective gloves have been divided according to European directives into 2 categories: medical devices and personal protective equipment (Quango of the European Communities, 1989b, 1993). Private glove brands cannot be certified according to both directives (D. Goltz, a representative of the glove benefactor Kimberly Clark, Finland, personal communication 2002; T. Laatikainen, a representative of the glove distributor Tamro MedLab, Finland, personal communication 2002). The gloves used in patient care are medical gloves and therefore it is of import to also test their protection efficiency confronting chemicals. According to the occupational safety regulations (Quango of the European Communities, 1989a), workers treatment hazardous chemicals should wear chemic protective gloves conforming to the personal protective equipment directive.
In healthcare utilize at that place are 4 types of common disposable gloves, surgical, sterile examination, not-sterile examination and non-sterile unclassified gloves. Surgical gloves are usually made from natural rubber (NR), but there are besides gloves made from plastic materials (e.g. polyvinyl chloride, vinyl, PVC) and synthetic prophylactic materials [east.one thousand. chloroprene rubber (CR), styrene-butadiene rubber] (Mellström and Boman, 1994; Douglas et al., 1997; Korniewicz and Rabussay, 1997). In Finland the examination gloves in utilize are normally either PVC or NR, simply other materials such as nitrile safety also be ( Palosuo et al., 1998). Examination gloves announced to be made of thinner materials (0.one–0.eighteen mm) than surgical gloves (0.17–0.3 mm) (Forsberg and Keith, 1999). The group of not-sterile unclassified gloves includes the thin transparent gloves that are made by joining two apartment polyethene films. These seamed gloves have seldom been classified for either healthcare or occupational safety purposes. The rubber materials have better tensile force and elasticity than plastic materials. In everyday apply during loftier stress applications vinyl gloves often suspension ( Korniewicz et al., 1989, 1993; Douglas et al., 1997; Neal et al., 1998). One unique class of gloves are those gloves with thick fingertips meant for the handling of cytotoxic drugs (Mellström and Boman, 1994).
Chemical permeation is the improvidence of chemicals through intact materials. Many chemicals permeate gloves without visibly affecting the materials and thus proceeds admission to the skin in an insidious way. If a chemical permeates through the glove, it may crusade adverse furnishings to the skin or it can be captivated through the skin and cause exposure effects elsewhere in the trunk (Leinster, 1994). Fifty-fifty normally quite harmless chemicals tin damage the pare if the exposure is frequent or prolonged (Mansdorf, 1994b). Furthermore, the inertness of the glove material to the chemical in use is important, considering if one chemical degrades the glove material, information technology tin help in the permeation of other chemicals (Sansone and Tewari, 1978; Castegnaro et al., 1982; Stampfer et al., 1984) or microorganisms ( Klein et al., 1990; Richards et al., 1993). Information technology is crucial to be aware that chemic permeation through disposable gloves can sometimes exist efficient and rapid (Mansdorf, 1987; Endicott, 1998; Blayney, 2001).
Composite resin materials, cytotoxic drugs and disinfectants have previously been shown to permeate through medical gloves and these studies have been reviewed past Mellström et al. (1996). Methyl methacrylate used in orthopaedic surgery is the best known chemic against which safety surgical gloves fail to offer protection (Pegum and Medhurst, 1971; Waegemaekers et al., 1983; Darre et al., 1987; Jensen et al., 1991). It has also been shown that examination gloves do not provide adequate protection against many cytotoxic drugs, and thus surgical gloves take been examined to identify which of these gloves acts as an adequate barrier to these agents ( Connor et al., 1984; Laidlaw et al., 1984; Slevin et al., 1984; Colligan and Horstman, 1990; Dinter-Heidorn and Carstens, 1992; Connor, 1995, 1999; Klein et al., 1999; Singleton and Connor, 1999). A written report by Connor and Xiang showed that a 5 min contact with 70% isopropyl alcohol does non increase the permeation of cytotoxic drugs through NR or nitrile prophylactic cloth. Thus, disinfection with isopropyl alcohol solution does not enhance the exposure of healthcare workers to these agents (Connor and Xiang, 2000).
The use of disinfectants is of import in surgical settings and some chemical permeation studies accept been performed on disposable gloves with disinfectants and cleansing agents ( Mellström et al., 1992; Lehman et al., 1994; Monticello and Gaber, 1999). However, only 3 studies which included surgical gloves take been found ( Nelson et al., 1981; Schwope et al., 1988a; Jordan et al., 1996). These studies depict permeation tests confronting glutaraldehyde, ethanol and formaldehyde and they indicate that surgical gloves can sometimes safeguard the user when examination gloves would fail.
In this communication nosotros offer guidance for selecting gloves confronting chemicals, while it is appreciated that the chore in mitt together with the backdrop of the chemical in employ must play an important office in any choice of gloves (Berardinelli, 1988; Calmbacher, 1993; Curtis et al., 1993; Mansdorf, 1994a). Providing recommendations without accurate knowledge of the task in question tin can be misleading, but since interpretation of permeation data ( Schwope et al., 1988b; Jamke, 1989; Leinster, 1994) has been considered to exist 'country-of-the-art' or at least hard in work places, some guidance does non seem awry.
In this report the permeability of surgical gloves to disinfectants and components usually present in cleansing agents was measured. The test chemicals were formaldehyde (37%), potassium hydroxide (45%), sodium hypochlorite (13%) and hydrogen peroxide (xxx%) and the iii commercial disinfectant solutions Dialox™, Cidex Long Life™ and Hibiscrub™. The surgical gloves studied included four NR single layered brands, two NR double layered brands and one CR brand. The chemical permeation tests were carried out using the current American and European standards for permeation testing, ASTM F739 and EN 374 (European Commission for Standardization, 1994; ASTM, 1999). These define the test weather and a two-chambered exam jail cell for measuring chemical permeation through a flat protective material. In most of the tests, an automated valve system was used to sample the collection medium (water) outflow of the test prison cell. Belittling methods that have not previously been reported for use in permeation testing were tailored to the tests. The applied methods were based on ion chromatography, liquid chromatography and automated spectrophotometry.
MATERIALS AND METHODS
Vii brands of surgical gloves were studied (Table one). One of the glove materials was CR, the rest were NR gloves. Half-dozen of the gloves came from the same factory and they had a polymeric Biogel® inner blanket. Two of the glove brands were double layered gloves with a nighttime green glove worn underneath a pale yellow glove, which allows holes in the material created during surgical operations to be seen (Laine and Aarnio, 2001). The supplier of the gloves was SSL International plc (Oldham, Uk). Co-ordinate to the supplier, these products accommodate to the requirements for surgical gloves co-ordinate to the Council Directive for Medical Devices and their acceptable quality level (AQL) is 1.five.
The chemicals tested were common infirmary disinfectants or substances present in disinfectants or in other cleansing agents. Hydrogen peroxide (thirty%), potassium hydroxide (45%) and sodium hypochlorite (xiii%) were studied in more concentrated forms than the products in common use. Dialox™ is a 0.35% peracetic acid solution that contains 3–five% acerb acrid and hydrogen peroxide. Cidex Long Life™ is a glutaraldehyde solution (2%). Peracetic acid solutions are gradually displacing glutaraldehyde equally instrument disinfecting agents. Hibiscrub™ is a mutual disinfectant for skin and contains chlorhexidine gluconate (4%) equally the active amanuensis. The formaldehyde solution (37%) had methyl alcohol as the stabilizing agent. Hibiscrub™ and Dialox™ were ready-made solutions whereas for Cidex Long Life™ the accompanying activating agent was added equally per the manufacturer's instructions. The tests were carried out well before the decease dates of the test solutions. The chemicals and their descriptions, which are required to be reported by the standard methods, are detailed in Tabular array 2.
The permeation test method standards ASTM F739 and EN 374 were followed, except that the maximum testing time used was 4 instead of the viii h stated past the EN standard. The glove samples were clamped betwixt the chambers of the test cells. The collection medium (water) was pumped through one chamber by a peristaltic pump (model 505S; Watson-Marlow Ltd, Falmouth, Britain) and the examination chemicals were injected into the other sleeping accommodation. Open up loop methods were used, i.e. fresh HPLC class h2o was passed through the cell at a steady rate during the whole test. Advisable flow rates (Table 3) for each analytical method were used, since the test standards practice not require any specific flow rates. These flow rates were checked at the outset of the tests and during each test. Magnetic stirrers made from polytetrafluoroethylene (PAM Solutions Ltd, Helsinki, Finland) were used to achieve adequate mixing levels in the test cells. The collection medium outflow was sampled periodically in order to mensurate the permeation rates of the test chemicals through the glove materials.
The ion chromatographic, liquid chromatographic and spectrophotometric test methods for measuring the test chemic in the collection medium are summarized in Table 3. The instruments were calibrated daily and checked subsequently and during the tests when applicable. Calibration was performed with appropriate chemicals in the concentration range covering the concentrations at which the breakthrough times (BTTs) were detected. The examination temperature was 23.0 ± 1.0°C. The temperature of the test chemicals and the water used as the collection medium were regulated using a water bathroom. The thickness measurement was carried out according to the standard ISO 4648. The glove samples were prepared and the results were calculated equally described in standards ASTM F739 and EN 374 and as reported elsewhere in item ( Mäkelä et al., 2003).
BTT is the time between awarding of the test chemical into the test cell and the time when the permeation rate exceeds a level of 0.1 (ASTM) or ane.0 µg/cm2/min (EN). The results of the tests are given as arithmetic ways of three BTT measurements.
Iii different glove materials were tested for all vii chemicals: the thinnest NR glove (Biogel® Super Sensitive), the NR glove without the Biogel® coating (Regent® Surgical) and the CR glove (Skinsense™ Northward). The rest of the NR gloves were not tested for those chemicals which did not evidence whatever permeation through the thinnest NR glove material.
Formaldehyde was measured by HPLC/UV afterward derivatization ( Levin et al., 1996; Priha, 1996). The drove medium menstruum rate was 20.6 ± 0.half dozen ml/min. Manual sampling from the outlet of the test cells was started for each test with a sampling rate of ane sample/ 5 min, and was gradually reduced to 1 sample/20 min. The 1 ml liquid samples were added directly into mixtures of 2 ml of 0.three thousand/l 97% two,iv-dinitrophenyl hydrazine (DNPH) (Aldrich) in acetonitrile (HPLC far UV course; LabScan Belittling Sciences) and 0.5 ml of 4 G hydrochloric acid. Afterward gentle mixing and keeping the samples for ii h at room temperature, they were analysed using a HPLC system consisting of 2 Waters 510 pump units, a Waters 717 plus autosampler and a Waters 996 photodiode array detector (Waters, Milford, MA). A Spherisorb S5 column (ODS 2, 250 × 4.vi mm) and acetonitrile/h2o eluent (65:35) were used. The calibration samples were prepared by dissolving formaldehyde 2,iv-DNP hydrazone (European Customs Agency of Reference BCR, reference material no. 546) into acetonitrile at concentrations of 0.04–2.2 mg/50 and prepared as for the samples. Linear responses were detected. Recoveries for formaldehyde were measured from samples of the test chemical in 10% methanol/h2o solutions at concentrations equivalent to the breakthrough detection levels. For the recovery measurements, the concentration of the test chemical was determined using an iodometric method (Finnish Standards Association, 1981). The exam chemical (∼37%) was found to contain 38.eight% (w/5) formaldehyde. The recoveries were 89.0 ± 6.3 (ASTM) and 93.2 ± one.half dozen% (EN).
The permeation of peracetic acid and acetic acid from Dialox™ was measured past ion chromatography. An automatic valve system (six port valve V340 with V1001 electric actuator; Upchurch Scientific, Oak Harbor, WA; valve actuator program IC version 1.0 by Matti Jussila) was used to direct the collection medium period into the injector valve of the ion chromatograph (DX-100; Dionex Corp., Sunnyvale, CA). The valve plan too actuated the anion chromatographic run every 5.3 min. The drove medium flow rate was 8.3 ± 0.iii ml/min. Three parallel glove samples were tested simultaneously. Dionex AS14 analytical (four × 250 mm) and AG14 (4 × 10 mm) baby-sit columns and an ASRS-I anion self-regenerating suppressor (4 mm) were used with the eluent 3 mM NaiiCOii/ane mM NaHCO3, the flow rate beingness 0.91 ml/min. The acids eluted with the same retention time. The response was measured confronting calibration samples in the range 0.19–2.seven mg/l and in which the ratio of peracetic acid to acerb acid was 39:61. The permeation of hydrogen peroxide contained in the Dialox™ solution was not measured.
Simply the permeation of glutaraldehyde was studied for Cidex Long Life™ solution. The test arrangement was the same as in the testing of formaldehyde. The drove medium flow rate was 19.viii ± 0.viii ml/min. Glutaraldehyde 2,4-DNP hydrazone (European Community Agency of Reference BCR, reference textile no. 550) calibration samples were in the concentration range 0.039–1.43 mg/l. A cubic through zero curve fit was used which resulted in R 2 values of 0.998. The HPLC eluent menses rate was 1.iii ml/min and the ratio of acetonitrile and h2o lxx:xxx. Glutaraldehyde (Aldrich) at p.a. grade l% was used to test the recovery of the method. The solution was measured titrimetrically and found to incorporate 53.0% (w/v) glutaraldehyde. The recoveries for samples equivalent to the breakthrough detection levels were 66 ± thirteen (ASTM) and 97 ± ane% (EN). In Cidex Long Life™ ii.one% (w/v) glutaraldehyde was found, whereas it nominally independent 2.0% (w/v).
Tests studying the permeation of chlorhexidine digluconate from Hibiscrub™ were carried out with the same equipment every bit for Dialox™ with the exception of using the ion chromatograph as a liquid chromatograph. A UV/VIS detector (259 nm, SPD-6AV; Shimadzu Corp.) was connected to the outlet of the belittling column, which was Supelcosil LC-xviii-DB (4.6 × 250 mm). Eluent consisting of 50% (v/v) methanol (p.a. grade; Labscan), 19.4% acetonitrile (p.a. course; Labscan), 0.6% triethylamine (p.a. grade; Fluka) and 30% h2o was adapted to pH 3 with concentrated phosphoric acid. The eluent catamenia rate was 1.05 ml/min. The method was an in-house modification of a method reported for amines (Vainiotalo, 1993; Vainiotalo and Matveinen et al., 1993). The collection medium catamenia rate from the exam cells was ix.iv ± 0.6 ml/min and three parallel tests were carried simultaneously. A sample (10 µl) from each jail cell was analysed every 16 min. The results were calculated from calibration standards of commercial chlorhexidine gluconate (20% w/v; Sigma).
Potassium hydroxide testing was carried out with the same equipment every bit for Dialox™, but using cation exchange columns (Ionpac CS12A 4 × 250 mm and CG12A iv × 50 mm; Dionex), a CSRS-Ultra self-regenerating suppressor (four mm) and 15 mM sulphuric acid (diluted from 0.v Yard sulphuric acid, Titrisol®; Merck) eluent at a flow rate of 1.5 ml/min. The collection medium flow charge per unit was xiii.0 ± 2.5 ml/min. Three parallel tests were carried out simultaneously. The chromatograph analysed a sample (50 µl) from every cell every 13 min. Commercial potassium hydroxide volumetric standard (0.1025 M; Aldrich) was diluted to v concentrations ranging from 0.092 to 1.84 mg/l for calibration of the cation chromatographic analysis. The response was linear.
Sodium from sodium hypochlorite was measured using ion chromatography following transmission sampling and reduction of the hypochlorite. Samples (4.nine ml) were pipetted from the collection medium flow (rate 14.0 ± 1.3 ml/min) from the test cells and 100 µl of 15 mM sulphuric acid was added to liberate the oxygen from the hypochlorite. The samples were sonicated for 15 min prior to analysis. At the beginning of the tests the sampling rate was every v min; at the end of the tests information technology was prolonged to every 15 min. The aforementioned ion chromatographic conditions were used as for potassium hydroxide assay except for the eluent menses charge per unit, which was ane.3 ml/min. Calibration samples were dissolved and diluted from stale sodium sulphate (p.a. grade; Merck). Five concentrations were used containing sodium sulphate from 0.11 to one.76 mg/l and the response was linear.
Hydrogen peroxide was detected using an automated spectrophotometric method based on oxidation of iodide by hydrogen peroxide. The same automated sampling system was used as in the Dialox™, Hibiscrub™ and potassium hydroxide testing. The ion chromatography column was replaced past a coiled reactor and restrictor tubing, which consisted of 6 cm polyetheretherketone (PEEK) (i.d. 0.five mm), xvi cm polyethene (i.d. 1 mm), 97 cm PEEK (i.d. 0.5 mm), 216 cm PEEK (i.d. 0.25 mm). The UV/VIS detector was set to a wavelength of 350 nm. The injector loop was 25 µl. The eluent was prepared by adding 20 ml of sodium iodide (10 thou/50 in h2o), five ml of sulphuric acid (96%), v ml of ammonium heptamolybdate (3 one thousand/l in water) and 250 µl of iodine solution (0.05 M Titrisol®; Merck) to water and adjusting the book to 500 ml. In the analysis the hydrogen peroxide oxidized iodide to iodine and tri-iodide. Iodine was added to the eluent every bit a stabilizer and ammonium heptamolybdate catalysed the reaction. The eluent menstruation rate was 0.34 ml/min. The sample concentrations of iodine were lower than the eluent concentrations and thus negative elevation detection was used. The concentration of the commercial 30% (w/v) hydrogen peroxide was determined by an iodometric method using sodium thiosulphate. The result was 33.0% (due west/v). The concentration levels of hydrogen peroxide (0.330 and three.thirty mg/l) for BTT determination corresponded to 0.58 ± 0.03 and xv.0 ± 0.2 mg/l iodine in the examination system. Scale samples were diluted from a 0.05 M Titrisol® iodine solution. Iodine concentrations between 1.two and 15 mg/l resulted in a linear fit. The detection limit of the method was 0.33 mg/50 hydrogen peroxide in water. The collection medium period rate was 6.one ± 0.3 ml/min. All the samples from the drove medium flow were programmed to be analysed between a sample of pure water and a solution containing 0.57 mg/l iodine. The injection frequency to the ion chromatograph was 4.two min and 2 glove samples were tested simultaneously. This meant that a sample was taken from each exam cell outflow every 17 min.
RESULTS
Clarification of the materials
The standardized methods require that glove thicknesses and the weight per unit of measurement area values must exist reported; these are shown in Table 1. The test chemical data is presented in Table 2.
Potassium hydroxide (45%), sodium hypochlorite (thirteen%), hydrogen peroxide (30%), Cidex Long Life™ and Hibiscrub™ permeation
The gloves did non evidence any permeation of potassium hydroxide, sodium hypochlorite or hydrogen peroxide. Neither did the glutaraldehyde nor the chlorhexidine gluconate present in the commercial disinfectant solutions show whatsoever permeation through the gloves under the weather condition used (Table iv).
Formaldehyde permeation
Formaldehyde permeation of the single layered NR gloves was first detected within 4–xx min at a level of 0.03 µg/cmii/min. The thinner double layered glove, the Biogel® Indicator, showed permeation initially at 75 min and the thicker Biogel® Reveal glove at 100 min. The CR glove, the Skinsense™ N, first showed permeation at a test time of 140 min. The BTTs according to the standard ASTM F739 were 17, 38, 37 and 67 min for the Biogel® Super Sensitive, Regent® Surgical, Biogel® and Biogel® Orthopaedic, respectively (Table four). The Biogel® Indicator, Biogel® Reveal and Skinsense™ Northward gloves did not reach the permeation rate required for a BTT to be assigned. A graphical presentation of the BTTs is shown (permeation rate 0.one µg/cm2/min) in Fig. 1. For the BTTs in the EN tests the aforementioned raw data could accept been utilized, just in none of the tests did the permeation rate exceed the limit of 1.0 µg/cm2/min.
If the permeation charge per unit reaches a steady-country level (a constant rate of permeation), the ASTM standard requires that this must be reported. In the test for permeation of formaldehyde through the Biogel Super-Sensitive glove a level of 0.five µg/cmii/min was reached, that beingness the only steady-land permeation rate attained in these tests.
Dialox™ permeation
The unmarried layered NR gloves allowed slight permeation of peracetic acid and acerb acid from the Dialox™ solution. The total permeation of peracetic and acetic acids at the ASTM level of 0.ane µg/cm2/min was exceeded in only 1 sample of the thinnest NR, Biogel® Super Sensitive glove. The permeation was first detected 2 h after insertion of the test chemical and the permeation charge per unit stayed near the level of 0.i µg/cm2/min until the end of the examination (Fig. 2). The Regent® Surgical and the Biogel® gloves and the two other samples of the Biogel® Super Sensitive glove were also permeable to the acids in the Dialox™ solution, merely in the four h exam they never reached a loftier enough level to permit BTT conclusion.
Word
Potassium chloride and sodium hypochlorite
The test results with the concentrated solutions of potassium chloride and sodium hypochlorite show that the NR and CR gloves studied are able to protect against these two chemicals in conventional hospital work where in that location is usually contact with less concentrated chemicals and where contact is for short periods of chemical usage. Nevertheless, should these chemicals be used in mixtures with highly glove-permeable or glove-degrading chemicals or the mechanical stress is greater than the gloves tin can stand up, then the results will exist not applicable. The results found for thin NR gloves in the compendium of permeation indices (Forsberg and Keith, 1999) agree with the study results.
Hydrogen peroxide
The concentrated hydrogen peroxide did non permeate through the studied NR and CR surgical gloves. Previously permeation of hydrogen peroxide (7.v%) through PVC and NR exam gloves has been reported to occur in <thirty min. The testing of NR gloves had been stopped afterward iii h, because the permeation rate had been accelerating at a rate too loftier to be meaningful (Monticello and Gaber, 1999). The ASTM standard with a closed loop system had been used in the tests. One of the likely reasons for the differences between those results and the results of this study may be the glove thicknesses and materials, considering the thinnest gloves used in this study still have double the thickness of the gloves examined in the Monticello and Gaber study. The compendium of permeation indices (Forsberg and Keith, 1999) presents 1 BTT of 150 min for NR gloves with a thickness of 0.15 mm; the other BTTs for NR gloves (0.xv–0.73 mm) are >360 or >480 min, which means that permeation has non been detected. In the compendium at that place is no published data for CR surgical gloves, but for industrial CR glove materials BTTs of v–>480 min are reported. The conclusion fatigued for those situations in which test gloves must be used for protection against concentrated hydrogen peroxide is that only gloves which accept been determined to provide the required protection should exist used.
Peracetic acid and glutaraldehyde solutions
No difficulties should ascend in finding protective gloves confronting either of these dilute solutions. Nonetheless, only gloves that accept been shown to provide protection should exist used. The gloves used in this study, even the thinnest NR gloves, should provide protection in direct contact with Dialox™ solution for 1 h, if the mechanical stress on the glove is kept to a minimum. Peracetic acid and glutaraldehyde tin also be used at higher concentrations. Due to the depression permeation of Dialox™, the permeation data for those concentrated solutions must exist used when selecting gloves confronting them. Although the Dialox™ solution as well contains hydrogen peroxide, testing of the permeation of hydrogen peroxide from Dialox™ was considered unnecessary, because the thirty% hydrogen peroxide did non permeate the gloves and the permeation of peracetic acid and acetic acid was minor. Lehman et al. (1994) earlier noted that the permeation of dilute glutaraldehyde through NR or Tactylon® exam gloves is nil or very low afterward 4 h of testing if the glove samples are not stretched. Permeation of Cidex™ has also been tested through thin NR, PVC and polyethene gloves and no show of glutaraldehyde permeation was detected ( Mellström et al., 1992). On the other manus, Jordan et al. (1996) have reported that a two% glutaraldehyde solution tin can permeate through rather sparse NR gloves in 45 min.
Chlorhexidine
Chlorhexidine is used in various disinfectant products. It is unlikely that chlorhexidine, which is polar and of large molecular size, would be able to permeate through rubber gloves unless there are chemicals in the product that dethrone the glove material. Solvents, due east.yard. alcohols, could assist chlorhexidine permeation.
Formaldehyde
Formaldehyde is a articulate adventure chemical and it should not be allowed to gain admission to the skin frequently or to any peachy extent. Thus, double gloving is recommended because of the risk of pinholes in the glove fabric and considering of the reduced chemical permeation. The thinner double layered glove in this study, the Biogel Indicator, would provide a relatively safe menstruation for working with formaldehyde of 30 min at a mechanically lite task, even if the task included continuous contact with the chemical.
It is typical that the permeation of formaldehyde increases very slowly during the permeation tests resulting in a low steady-state permeation rate. This type of permeation rate contour makes the exam results difficult to reproduce with the unlike methods in utilise in separate laboratories. Even small-scale changes in examination conditions can cause major differences. In the instance of formaldehyde we volition list a few of the critical examination parameters. The drove medium can be either gaseous or liquid and the detection limit of the belittling method may be higher than the formaldehyde concentration corresponding to a permeation charge per unit of 0.1 µg/cm2/min. In such a case, the permeation can be extrapolated backwards from the higher detected concentrations. There may too exist difficulties due to the volatility and polymerization backdrop of formaldehyde. When these facts are added to the differences in glove materials, the broad range of BTTs (from 4 to >360 min) in the permeation index compendium should not come as a surprise (Forsberg and Keith, 1999). A previous study into formaldehyde permeation describes methods that were applied to three brands of NR and 1 blazon of CR gloves ( Schwope et al., 1988a). The results for 0.17 mm thick NR surgical gloves ranged from ane to 15 min and the steady-state permeation rates from 0.i to 1.0 µg/cmtwo/min. Thus, our information are consistent with the data of Schwope et al. taking into consideration the differences in the materials and the non-standardized methods.
Chloroprene rubber
The CR gloves were the thinnest gloves in our written report and clearly offered the all-time protection against formaldehyde. It is unfortunate that this make is planned to be sold only as unmarried-packed sterilized surgical, and thus loftier priced, gloves. These CR gloves as well offered good protection functioning against 70% isopropyl alcohol ( Mäkelä et al., 2003). Additionally, a previous CR surgical glove textile has proved to be an effective bulwark against a mixture of methacrylates ( Mäkelä et al., 1999). Schwope et al. (1988a) have also concluded that CR gloves are superior to NR and PVC gloves as a bulwark against formaldehyde.
Glove thickness
The thicker the NR gloves, the improve barriers they provided against formaldehyde every bit well equally isopropyl alcohol ( Mäkelä et al., 2003). The results for the Regent® Surgical glove were consequent with the others, although it had no Biogel® blanket and was from a different production unit. The choice of not testing all the gloves for all the exam chemicals proved reliable. The thick or double layered NR gloves which were not tested for all the chemicals tin can be safely used for protection confronting chemicals that did not permeate through the thin NR gloves.
Different permeation levels for BTT conclusion of the standards
The level of the ASTM standard, 0.1 µg/cm2/min, yields shorter BTTs than the EN standard nether the same test atmospheric condition. For the user of the gloves this is naturally safer: witness that formaldehyde did not result in a BTT at all using the EN standard in this study. On the other hand, the ASTM standard requires depression detection limits for the test chemicals, which complicates the testing methods for some chemicals. In the instance of gaseous drove media, the flow rate is different in these two standardized methods and this sometimes affects the results ( Mäkelä et al., 2003). Thus, fifty-fifty though there is a need for uniform standards, it is difficult to state which kind of examination weather condition should be selected for the harmonized standard.
Improving the condom of gloves used in the medical health services
To protect healthcare workers from the hazardous effects of chemicals, the regulations should be altered and the testing of medical gloves should be mandatory against chemicals and medical substances. Since permeation depends on both the exam chemical and the glove make, all the brands that are used in the handling of chemicals need to exist tested.
The present exercise of glove certification with different categories either for medical or other protective purposes should be abandoned and the same glove brands should be certified for both uses.
The goal of standardization should exist the harmonization of test methods for all leak-tight gloves that are used to protect against chemicals, microbes or medications. Uniform tests would facilitate the interpretation of the results, make the selection of gloves easier and continue the testing costs reasonable.
Even if chemic permeation tests are not required of the manufacturers of medical gloves at present, the test information may exist produced and provided as additional information. The healthcare personnel treatment chancy chemicals and medications must exist trained to observe and to know how to use this data. Furthermore, detailed studies on chemical, bacterial and viral protection provided by disposable gloves in everyday apply are conspicuously needed.
Acknowledgements—This report was made possible by the kind financial and textile support of SSL International plc, Oldham, UK.
* Writer to whom correspondence should be addressed. E-mail: erja.makela@ttl.fi
§ Current accost: National Veterinary and Food Enquiry Institute, PO Box 45, FIN-00580 Helsinki, Finland
Name | Material | Thickness (mm) | Weight per unit expanse (k/mii) |
Skinsense™ Due north | CRa + BCb | 0.xix | 255 |
Biogel® Super Sensitive | NRc + BC | 0.22 | 197 |
Regent Surgical | NR | 0.28 | 220 |
Biogel® | NR + BC | 0.27 | 244 |
Biogel® Orthopaedic | NR + BC | 0.37 | 302 |
Biogel® Indicator | NR + BC | ||
Inner glove | 0.22 | 199 | |
Outer glove | 0.22 | 202 | |
Biogel® Reveal | NR + BC | ||
Inner glove | 0.31 | 251 | |
Outer glove | 0.29 | 241 |
Name | Material | Thickness (mm) | Weight per unit of measurement area (g/m2) |
Skinsense™ Due north | CRa + BCb | 0.19 | 255 |
Biogel® Super Sensitive | NRc + BC | 0.22 | 197 |
Regent Surgical | NR | 0.28 | 220 |
Biogel® | NR + BC | 0.27 | 244 |
Biogel® Orthopaedic | NR + BC | 0.37 | 302 |
Biogel® Indicator | NR + BC | ||
Inner glove | 0.22 | 199 | |
Outer glove | 0.22 | 202 | |
Biogel® Reveal | NR + BC | ||
Inner glove | 0.31 | 251 | |
Outer glove | 0.29 | 241 |
aChloroprene rubber.
bBiogel® coating.
cNatural rubber.
Name | Material | Thickness (mm) | Weight per unit area (g/10002) |
Skinsense™ Due north | CRa + BCb | 0.19 | 255 |
Biogel® Super Sensitive | NRc + BC | 0.22 | 197 |
Regent Surgical | NR | 0.28 | 220 |
Biogel® | NR + BC | 0.27 | 244 |
Biogel® Orthopaedic | NR + BC | 0.37 | 302 |
Biogel® Indicator | NR + BC | ||
Inner glove | 0.22 | 199 | |
Outer glove | 0.22 | 202 | |
Biogel® Reveal | NR + BC | ||
Inner glove | 0.31 | 251 | |
Outer glove | 0.29 | 241 |
Name | Material | Thickness (mm) | Weight per unit area (one thousand/m2) |
Skinsense™ N | CRa + BCb | 0.19 | 255 |
Biogel® Super Sensitive | NRc + BC | 0.22 | 197 |
Regent Surgical | NR | 0.28 | 220 |
Biogel® | NR + BC | 0.27 | 244 |
Biogel® Orthopaedic | NR + BC | 0.37 | 302 |
Biogel® Indicator | NR + BC | ||
Inner glove | 0.22 | 199 | |
Outer glove | 0.22 | 202 | |
Biogel® Reveal | NR + BC | ||
Inner glove | 0.31 | 251 | |
Outer glove | 0.29 | 241 |
aChloroprene rubber.
bBiogel® coating.
cNatural rubber.
Name | Supplier | Nominal concentration | Measured concentration | Other components |
Formaldehyde solution, A.C.Southward. reagent | Aldrich Chemie GmbH, Steinheim, Germany | 37% (westward/v) | 38.8% (westward/5) | Methyl alcohol 10–xv%, water |
Dialox™ | Seppic, Paris, France | Peracetic acid 0.35% and acerb acid 3–five% | four.0% (westward/v) | Hydrogen peroxide, water |
Cidex Long Life™ | Johnson & Johnson Medical, Sollentuna, Sweden | Glutaraldehyde 2.0% | 2.i% (w/5) | Peppermint oil, surfactant, potassium acetate, potassium phosphate, colour, water |
Hibiscrub™ | Zeneca Ltd, Macclesfield, United kingdom | Chlorhexidine gluconate 4% (w/five) | Polyoxyethylene polyoxypropylene block co-polymer, lauryl dimethyl amine oxide, ponceau 4R, isopropyl alcohol, perfume, d-glutanolactone and water | |
Potassium hydroxide solution | Aldrich Chemical Co., Milwaukee, WI | 45% (w/v) | H2o | |
Sodium hypochlorite solution | BDH Laboratory Supplies, Poole, U.k. | Available chlorine ≥ 12% | Sodium hydroxide, water | |
Hydrogen peroxide solution, Reag. ISO, Reag. Ph. Eur. | Riedel-de Haën, Seelze, Deutschland | xxx% | 33.0% (w/5) | Stabilizer, water |
Name | Supplier | Nominal concentration | Measured concentration | Other components |
Formaldehyde solution, A.C.S. reagent | Aldrich Chemie GmbH, Steinheim, Germany | 37% (w/5) | 38.eight% (westward/v) | Methyl alcohol ten–xv%, h2o |
Dialox™ | Seppic, Paris, French republic | Peracetic acrid 0.35% and acetic acid three–5% | 4.0% (due west/five) | Hydrogen peroxide, h2o |
Cidex Long Life™ | Johnson & Johnson Medical, Sollentuna, Sweden | Glutaraldehyde 2.0% | two.1% (w/5) | Peppermint oil, surfactant, potassium acetate, potassium phosphate, colour, water |
Hibiscrub™ | Zeneca Ltd, Macclesfield, Britain | Chlorhexidine gluconate four% (westward/five) | Polyoxyethylene polyoxypropylene block co-polymer, lauryl dimethyl amine oxide, ponceau 4R, isopropyl alcohol, perfume, d-glutanolactone and h2o | |
Potassium hydroxide solution | Aldrich Chemic Co., Milwaukee, WI | 45% (due west/v) | Water | |
Sodium hypochlorite solution | BDH Laboratory Supplies, Poole, Britain | Available chlorine ≥ 12% | Sodium hydroxide, water | |
Hydrogen peroxide solution, Reag. ISO, Reag. Ph. Eur. | Riedel-de Haën, Seelze, Germany | 30% | 33.0% (w/five) | Stabilizer, h2o |
Name | Supplier | Nominal concentration | Measured concentration | Other components |
Formaldehyde solution, A.C.S. reagent | Aldrich Chemie GmbH, Steinheim, Deutschland | 37% (w/v) | 38.8% (w/v) | Methyl alcohol 10–15%, water |
Dialox™ | Seppic, Paris, France | Peracetic acid 0.35% and acetic acid 3–5% | iv.0% (westward/v) | Hydrogen peroxide, water |
Cidex Long Life™ | Johnson & Johnson Medical, Sollentuna, Sweden | Glutaraldehyde 2.0% | ii.ane% (w/five) | Peppermint oil, surfactant, potassium acetate, potassium phosphate, colour, water |
Hibiscrub™ | Zeneca Ltd, Macclesfield, United kingdom of great britain and northern ireland | Chlorhexidine gluconate 4% (w/v) | Polyoxyethylene polyoxypropylene block co-polymer, lauryl dimethyl amine oxide, ponceau 4R, isopropyl alcohol, perfume, d-glutanolactone and h2o | |
Potassium hydroxide solution | Aldrich Chemic Co., Milwaukee, WI | 45% (w/five) | H2o | |
Sodium hypochlorite solution | BDH Laboratory Supplies, Poole, United kingdom of great britain and northern ireland | Available chlorine ≥ 12% | Sodium hydroxide, water | |
Hydrogen peroxide solution, Reag. ISO, Reag. Ph. Eur. | Riedel-de Haën, Seelze, Germany | thirty% | 33.0% (west/v) | Stabilizer, water |
Name | Supplier | Nominal concentration | Measured concentration | Other components |
Formaldehyde solution, A.C.S. reagent | Aldrich Chemie GmbH, Steinheim, Germany | 37% (w/v) | 38.8% (w/v) | Methyl alcohol 10–15%, water |
Dialox™ | Seppic, Paris, France | Peracetic acid 0.35% and acetic acrid 3–5% | 4.0% (w/v) | Hydrogen peroxide, water |
Cidex Long Life™ | Johnson & Johnson Medical, Sollentuna, Sweden | Glutaraldehyde 2.0% | 2.1% (w/v) | Peppermint oil, surfactant, potassium acetate, potassium phosphate, colour, water |
Hibiscrub™ | Zeneca Ltd, Macclesfield, United kingdom of great britain and northern ireland | Chlorhexidine gluconate iv% (westward/v) | Polyoxyethylene polyoxypropylene block co-polymer, lauryl dimethyl amine oxide, ponceau 4R, isopropyl alcohol, perfume, d-glutanolactone and water | |
Potassium hydroxide solution | Aldrich Chemic Co., Milwaukee, WI | 45% (west/five) | H2o | |
Sodium hypochlorite solution | BDH Laboratory Supplies, Poole, U.k. | Bachelor chlorine ≥ 12% | Sodium hydroxide, water | |
Hydrogen peroxide solution, Reag. ISO, Reag. Ph. Eur. | Riedel-de Haën, Seelze, Germany | 30% | 33.0% (w/v) | Stabilizer, water |
Examination chemic | Analyte | Collection medium flow rate (ml/min) | Sampling | Parallel tests at a time | Sampling frequency from 1 test jail cell (min) | Analytical method |
Formaldehyde 37% (w/five) solution | Formaldehyde | 20.half dozen ± 0.vi | Transmission | 2 | 5–20 | HPLC/UV, 2,4-dinitrophenyl hydrazone derivatives |
Dialox™ | Peracetate and acetate | viii.3 ± 0.three | Automated | 3 | 21.two | Anion chromatography |
Cidex Long Life™ | Glutaraldehyde | 19.8 ± 0.eight | Manual | two | v–xx | HPLC/UV, ii,4-dinitrophenyl hydrazone derivatives |
Hibiscrub™ | Chlorhexidine digluconate | 9.four ± ii.five | Automatic | iii | 16 | HPLC/UV |
Potassium hydroxide 45% (westward/v) solution | Potassium | xiii.0 ± two.5 | Automated | iii | 13 | Cation chromatography |
Sodium hypochlorite xiii% solution | Sodium | xiv.0 ± i.iii | Manual | 2 | 5–20 | Cation chromatography, reduction |
Hydrogen peroxide xxx% solution | Hydrogen peroxide | 6.one ± 0.iii | Automated | 2 | 17 | Automatic spectrophotometry, iodide reagent as an eluent |
Test chemical | Analyte | Collection medium catamenia rate (ml/min) | Sampling | Parallel tests at a fourth dimension | Sampling frequency from ane test cell (min) | Belittling method |
Formaldehyde 37% (westward/v) solution | Formaldehyde | 20.6 ± 0.6 | Transmission | 2 | 5–20 | HPLC/UV, two,4-dinitrophenyl hydrazone derivatives |
Dialox™ | Peracetate and acetate | eight.3 ± 0.3 | Automated | three | 21.2 | Anion chromatography |
Cidex Long Life™ | Glutaraldehyde | xix.8 ± 0.viii | Transmission | 2 | five–20 | HPLC/UV, 2,4-dinitrophenyl hydrazone derivatives |
Hibiscrub™ | Chlorhexidine digluconate | 9.4 ± 2.five | Automated | iii | xvi | HPLC/UV |
Potassium hydroxide 45% (w/v) solution | Potassium | thirteen.0 ± 2.5 | Automated | 3 | 13 | Cation chromatography |
Sodium hypochlorite 13% solution | Sodium | 14.0 ± 1.iii | Manual | 2 | five–twenty | Cation chromatography, reduction |
Hydrogen peroxide 30% solution | Hydrogen peroxide | vi.1 ± 0.3 | Automated | 2 | 17 | Automated spectrophotometry, iodide reagent as an eluent |
Examination chemic | Analyte | Collection medium menses rate (ml/min) | Sampling | Parallel tests at a time | Sampling frequency from one exam cell (min) | Analytical method |
Formaldehyde 37% (w/v) solution | Formaldehyde | 20.6 ± 0.6 | Manual | 2 | v–twenty | HPLC/UV, 2,4-dinitrophenyl hydrazone derivatives |
Dialox™ | Peracetate and acetate | 8.iii ± 0.3 | Automated | 3 | 21.2 | Anion chromatography |
Cidex Long Life™ | Glutaraldehyde | nineteen.8 ± 0.eight | Transmission | 2 | five–xx | HPLC/UV, two,four-dinitrophenyl hydrazone derivatives |
Hibiscrub™ | Chlorhexidine digluconate | ix.4 ± 2.5 | Automated | 3 | xvi | HPLC/UV |
Potassium hydroxide 45% (westward/v) solution | Potassium | 13.0 ± ii.5 | Automated | 3 | 13 | Cation chromatography |
Sodium hypochlorite thirteen% solution | Sodium | 14.0 ± 1.iii | Transmission | ii | five–20 | Cation chromatography, reduction |
Hydrogen peroxide 30% solution | Hydrogen peroxide | 6.1 ± 0.3 | Automatic | two | 17 | Automated spectrophotometry, iodide reagent as an eluent |
Test chemical | Analyte | Collection medium flow rate (ml/min) | Sampling | Parallel tests at a time | Sampling frequency from ane test jail cell (min) | Analytical method |
Formaldehyde 37% (westward/5) solution | Formaldehyde | 20.6 ± 0.6 | Manual | 2 | 5–20 | HPLC/UV, ii,iv-dinitrophenyl hydrazone derivatives |
Dialox™ | Peracetate and acetate | eight.3 ± 0.3 | Automated | three | 21.two | Anion chromatography |
Cidex Long Life™ | Glutaraldehyde | 19.viii ± 0.eight | Manual | 2 | 5–xx | HPLC/UV, 2,4-dinitrophenyl hydrazone derivatives |
Hibiscrub™ | Chlorhexidine digluconate | 9.4 ± 2.5 | Automated | 3 | 16 | HPLC/UV |
Potassium hydroxide 45% (w/5) solution | Potassium | 13.0 ± 2.5 | Automatic | iii | 13 | Cation chromatography |
Sodium hypochlorite 13% solution | Sodium | xiv.0 ± 1.3 | Manual | 2 | five–20 | Cation chromatography, reduction |
Hydrogen peroxide thirty% solution | Hydrogen peroxide | 6.one ± 0.3 | Automated | ii | 17 | Automatic spectrophotometry, iodide reagent as an eluent |
Table 4.
Glove | Formaldehyde 37% | Peracetic acid and acerb acid in Dialox | Glutaraldehyde in Cidex Long Life | Chlorhexidine gluconate in Hibiscrub | Potassium hydroxide 45% | Sodium hypochlorite thirteen% | Hydrogen peroxide 30% | |||||||||||||
EN | ASTM | EN | ASTM | EN | ASTM | EN | ASTM | EN | ASTM | EN | ASTM | EN | ASTM | |||||||
Skinsense™ Due north | * | * | – | – | – | – | – | – | – | – | – | – | – | – | ||||||
Biogel® Super Sensitive | * | 17 (xvi–19) | * | > 233 (189–>240) | – | – | – | – | – | – | – | – | – | – | ||||||
Regent Surgical | * | 38 (33–47) | * | * | – | – | – | – | – | – | – | – | – | – | ||||||
Biogel® | * | 37 (29–43) | * | * | ||||||||||||||||
Biogel® Orthopaedic | * | 67 (49–88) | – | – | ||||||||||||||||
Biogel® Indicator | * | * | – | – | ||||||||||||||||
Biogel® Reveal | * | * | – | – |
Glove | Formaldehyde 37% | Peracetic acid and acerb acrid in Dialox | Glutaraldehyde in Cidex Long Life | Chlorhexidine gluconate in Hibiscrub | Potassium hydroxide 45% | Sodium hypochlorite 13% | Hydrogen peroxide thirty% | |||||||||||||
EN | ASTM | EN | ASTM | EN | ASTM | EN | ASTM | EN | ASTM | EN | ASTM | EN | ASTM | |||||||
Skinsense™ N | * | * | – | – | – | – | – | – | – | – | – | – | – | – | ||||||
Biogel® Super Sensitive | * | 17 (16–xix) | * | > 233 (189–>240) | – | – | – | – | – | – | – | – | – | – | ||||||
Regent Surgical | * | 38 (33–47) | * | * | – | – | – | – | – | – | – | – | – | – | ||||||
Biogel® | * | 37 (29–43) | * | * | ||||||||||||||||
Biogel® Orthopaedic | * | 67 (49–88) | – | – | ||||||||||||||||
Biogel® Indicator | * | * | – | – | ||||||||||||||||
Biogel® Reveal | * | * | – | – |
Just the Skinsense Due north, Super Sensitive and the Regent Surgical were tested with all the chemicals. It was causeless that if the chemic did not permeate the thinnest natural rubber gloves (Super Sensitive) neither would it permeate the thicker gloves made from the same material. Numbers in parentheses indicate the range of the three parallel BTT results.
–, no permeation was observed during the 4 h exam.
*, permeation nether the limit of breakthrough detection was observed in the exam.
Table four.
Glove | Formaldehyde 37% | Peracetic acid and acetic acid in Dialox | Glutaraldehyde in Cidex Long Life | Chlorhexidine gluconate in Hibiscrub | Potassium hydroxide 45% | Sodium hypochlorite 13% | Hydrogen peroxide 30% | |||||||||||||
EN | ASTM | EN | ASTM | EN | ASTM | EN | ASTM | EN | ASTM | EN | ASTM | EN | ASTM | |||||||
Skinsense™ Northward | * | * | – | – | – | – | – | – | – | – | – | – | – | – | ||||||
Biogel® Super Sensitive | * | 17 (16–xix) | * | > 233 (189–>240) | – | – | – | – | – | – | – | – | – | – | ||||||
Regent Surgical | * | 38 (33–47) | * | * | – | – | – | – | – | – | – | – | – | – | ||||||
Biogel® | * | 37 (29–43) | * | * | ||||||||||||||||
Biogel® Orthopaedic | * | 67 (49–88) | – | – | ||||||||||||||||
Biogel® Indicator | * | * | – | – | ||||||||||||||||
Biogel® Reveal | * | * | – | – |
Glove | Formaldehyde 37% | Peracetic acid and acerb acid in Dialox | Glutaraldehyde in Cidex Long Life | Chlorhexidine gluconate in Hibiscrub | Potassium hydroxide 45% | Sodium hypochlorite 13% | Hydrogen peroxide 30% | |||||||||||||
EN | ASTM | EN | ASTM | EN | ASTM | EN | ASTM | EN | ASTM | EN | ASTM | EN | ASTM | |||||||
Skinsense™ North | * | * | – | – | – | – | – | – | – | – | – | – | – | – | ||||||
Biogel® Super Sensitive | * | 17 (sixteen–19) | * | > 233 (189–>240) | – | – | – | – | – | – | – | – | – | – | ||||||
Regent Surgical | * | 38 (33–47) | * | * | – | – | – | – | – | – | – | – | – | – | ||||||
Biogel® | * | 37 (29–43) | * | * | ||||||||||||||||
Biogel® Orthopaedic | * | 67 (49–88) | – | – | ||||||||||||||||
Biogel® Indicator | * | * | – | – | ||||||||||||||||
Biogel® Reveal | * | * | – | – |
Only the Skinsense Due north, Super Sensitive and the Regent Surgical were tested with all the chemicals. It was assumed that if the chemical did not permeate the thinnest natural rubber gloves (Super Sensitive) neither would it permeate the thicker gloves made from the same material. Numbers in parentheses betoken the range of the 3 parallel BTT results.
–, no permeation was observed during the 4 h test.
*, permeation under the limit of breakthrough detection was observed in the exam.
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Source: https://academic.oup.com/annweh/article/47/4/313/160050
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