Ability of 1000 mL Water Leak Test for Medical Gloves to Detect Gloves with Potential for Virus Penetration

Kotilainen, HR; Cyr, W. Howard; Truscott, Wava; Gantz, NM; Routson, L B; Lytle, C. David

doi:10.1520/stp19149s

Cited by 18 publications

(12 citation statements)

References 10 publications

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“…(5,6,15) A primary concern was the ability of the 1 L water-leak test to detect holes in the fingers and thumb. Preliminary investigation indicated this was an issue with holes made by a 21-gauge needle.…”

Section: Discussionmentioning

confidence: 99%

“…This possibility was anticipated based on the reported disparities from previous studies, (5,6) as well as on a report that indicated the inability of the water-leak test to identify holes in the index, middle, and ring fingers. (15) Most notably, the thumb and pinky regions were not evaluated in the previous studies, which was an area on concern. Thus, a standardized method was developed to detect holes in the finger, thumb, and palm regions.…”

Section: Methodsmentioning

confidence: 99%

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Integrity of Disposable Nitrile Exam Gloves Exposed to Simulated Movement

Phalen

Wong

2011

Journal of Occupational and Environmental Hygiene

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Every year, millions of health care, first responder, and industry workers are exposed to chemical and biological hazards. Disposable nitrile gloves are a common choice as both a chemical and physical barrier to these hazards, especially as an alternative to natural latex gloves. However, glove selection is complicated by the availability of several types or formulations of nitrile gloves, such as low-modulus, medical-grade, low-filler, and cleanroom products. This study evaluated the influence of simulated movement on the physical integrity (i.e., holes) of different nitrile exam glove brands and types. Thirty glove products were evaluated out-of-box and after exposure to simulated whole-glove movement for 2 hr. In lieu of the traditional 1-L water-leak test, a modified water-leak test, standardized to detect a 0.15 ± 0.05 mm hole in different regions of the glove, was developed. A specialized air inflation method simulated bidirectional stretching and whole-glove movement. A worst-case scenario with maximum stretching was evaluated. On average, movement did not have a significant effect on glove integrity (chi-square; p=0.068). The average effect was less than 1% between no movement (1.5%) and movement (2.1%) exposures. However, there was significant variability in glove integrity between different glove types (p ≤ 0.05). Cleanroom gloves, on average, had the highest percentage of leaks, and 50% failed the water-leak test. Low-modulus and medical-grade gloves had the lowest percentages of leaks, and no products failed the water-leak test. Variability in polymer formulation was suspected to account for the observed discrepancies, as well as the inability of the traditional 1-L water-leak test to detect holes in finger/thumb regions. Unexpectedly, greater than 80% of the glove defects were observed in the finger and thumb regions. It is recommended that existing water-leak tests be re-evaluated and standardized to account for product variability.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Integrity of Disposable Nitrile Exam Gloves Exposed to Simulated Movement

Phalen

Wong

2011

Journal of Occupational and Environmental Hygiene

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“…FDA, 2008). Thus, selection of disposable gloves resides primarily on the 1-l water-leak test results, which has been shown to not adequately protect against viral penetration (Kotilainen et al, 1992). Alternative standards and guidance do evaluate viral penetration, namely ASTM F 1671 (ASTM International, 2007).…”

Section: Glove Integritymentioning

confidence: 99%

“…However, product formulation and variability are not addressed in these standards. This is further complicated by indications that the existing 1-l water-leak test for watertightness, which is a basis of many standards such as American Society for Testing and Materials (ASTM) D 5151, EN 455-1, and NFPA 1999, does not adequately detect small holes in the fingers and thumb that could pass a virus (Kotilainen et al, 1992;Phalen and Wong, 2011). The ASTM has a test method for evaluating viral penetration (ASTM International, 2007), ASTM F 1671, which is also used in the NFPA 1999 Standard (NFPA, 2008), but it is not designed for post-production quality control and quality assurance testing.…”

Section: Introductionmentioning

confidence: 99%

Tensile Properties and Integrity of Clean Room and Low-Modulus Disposable Nitrile Gloves: A Comparison of Two Dissimilar Glove Types

2011

The Annals of Occupational Hygiene

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Background: The selection of disposable nitrile exam gloves is complicated by (i) the availability of several types or formulations, (ii) product variability, and (iii) an inability of common quality control tests to detect small holes in the fingers. Differences in polymer formulation (e.g. filler and plasticizer/oil content) and tensile properties are expected to account for much of the observed variability in performance.Objectives: This study evaluated the tensile properties and integrity (leak failure rates) of two glove choices assumed to contain different amounts of plasticizers/oils. The primary aims were to determine if the tensile properties and integrity differed and if associations existed among these factors. Additional physical and chemical properties were evaluated.Methods: Six clean room and five low-modulus products were evaluated using the American Society for Testing and Materials Method D412 and a modified water-leak test to detect holes capable of passing a virus or chemical agent.Results: Significant differences in the leak failure rates and tensile properties existed between the two glove types (P 0.05). The clean room gloves were about three times more likely to have leak failures (chi-square; P 5 0.001). No correlation was observed between leak failures and tensile properties. Solvent extract, an indication of added plasticizer/oil, was not associated with leak failures. However, gloves with a maximum modulus ,4 MPa or area density (AD) ,11 g cm À2 were about four times less likely to leak.Conclusions: On average, the low-modulus gloves were a better choice for protection against aqueous chemical or biological penetration. The observed variability between glove products indicated that glove selection cannot rely solely on glove type or manufacturer labeling. Measures of modulus and AD may aid in the selection process, in contrast with common measures of tensile strength and elongation at break.

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“…[13][14][15] For comparison, common pathogenic human viruses include hepatitis B (42 nm), human papilloma (45-55 nm), herpes simplex (120-150 nm), cytomegalovirus (120-150 nm), 16 and human immunodeficiency virus (90-130 nm). 17,18 The virus was assayed biologically (by infectivity) using standard microbiological methods, that is, the standard double agar layer method for coliphage plaque formation with E. coli C as the host bacterium.…”

Section: The Challenge Virusmentioning

confidence: 99%

Viral impermeability of hypoallergenic, low protein, guayule latex films

Cornish¹,

Lytle²

1999

J. Biomed. Mater. Res.

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Guayule latex proteins do not cross-react with antibodies raised against latex proteins in commercially available products manufactured from Hevea brasiliensis latex. Thus guayule latex is a promising raw material for the manufacture of hypoallergenic latex products, safe for use by people suffering from IgE-mediated Type I "latex allergy." Also, guayule latex is a low protein material and therefore unlikely to cause widespread sensitization. Latex products commonly are used as essential barriers against the transmission of disease, and so guayule hypoallergenic latex medical products would be a viable alternative only if they possess effective viral barrier properties. To address this question, fingers of prototype hand-dipped guayule latex examination gloves were tested for their permeability to a surrogate challenge virus, varphiX174. This virus has a diameter of 27 nm and is similar in size to the smallest human pathogenic viruses. Prototype guayule latex condom films were tested using synthetic blood over a range of pressures and, after 4 years of storage, with synthetic blood and with the varphiX174 virus. We concluded that guayule latex films taken from prototype hand-dipped gloves and condoms provide effective barriers to virus transmission and that they remain effective (at least in condoms) after long-term storage.

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Ability of 1000 mL Water Leak Test for Medical Gloves to Detect Gloves with Potential for Virus Penetration

Cited by 18 publications

References 10 publications

Integrity of Disposable Nitrile Exam Gloves Exposed to Simulated Movement

Integrity of Disposable Nitrile Exam Gloves Exposed to Simulated Movement

Tensile Properties and Integrity of Clean Room and Low-Modulus Disposable Nitrile Gloves: A Comparison of Two Dissimilar Glove Types

Viral impermeability of hypoallergenic, low protein, guayule latex films

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