A laboratory evaluation of standard leakage tests for surgical & examination gloves.
Analysis of leakage tests for surgical and examination gloves is reported. Six widely applicable tests were evaluated, using samples from 16 glove manufacturers. Various techniques for inducing sub-millimeter holes were developed and employed for creating test holes in a wide variety of gloves. The prescribed tests were performed and the results compared to calculations of expected sensitivities. In general, there was reasonable agreement between calculation and measurement (within about a factor of 2), although there were some exceptions. Minimum detectable hole sizes, before the holes were stretched by the tests, were generally in the range of 25-100 microns in diameter. Theoretical predictions of minimum detectable hole sizes for the various tests ranged from about 100-200 microns (in the stretched condition). Because of inherent limitations of the test protocols, it is clear that much larger holes can go undetected under certain circumstances, especially in examination gloves. Some test procedures had important procedural ambiguities; some tests were patently impossible to perform. All tests had inherent limitations resulting in sensitivities that varied from glove to glove or that were quite nonuniform over the surface of the glove being tested or both.
D004867:Equipment Design / Q000592:standards*; D004865:Equipment and Supplies, Hospital / Q000592:standards*; D005069:Evaluation Studies as Topic; D005932:Gloves, Surgical / Q000592:standards*; D008422:Materials Testing; D014481:United States