A Method for Assessing the Durability of Medical Examination Gloves

摘要

A method was developed to test the durability of medical examination gloves. Target failure rate ranges were established for the method by analysis of published failure rates for gloves tested after clinical use. The method consists of two parts: a Simulated Donning Test Procedure and a Shaker Table Abrasion Procedure. FDA water leak testing was performed to detect defects after stressing the gloves. In the donning procedure, a donning apparatus is used to simulate the stresses of donning medical gloves. In the abrasion procedure, a hand phantom is placed inside the glove; the glove is placed into a Fleaker~(TM) beaker containing an abrasive material; and a shaker table agitates the setup and stresses the glove. Failure rates were 4 percent for vinyl gloves and 0 percent for latex gloves after simulated donning alone and 41 percent for vinyl and 11 percent for latex after combined donning and abrasion testing. The measured failure rates were within the established target rate ranges.