L.N.Kerr, L.D.Cash, M.P.Chaput, L.G.O'Malley, E.M.Sarhrani, J.C.Teixeira, W.S.Boivin, S.A.Mailhot, WEAC, FDA, Winchester, MA 01890
Current test methods evaluate the presence of defects in finished product, not the dynamics of glove use. A method to assess the durability of medical examination gloves made of various materials was evaluated. For each glove type, three sets of 100 gloves were tested. The first set of gloves was “challenged” using the durability method. The second set was manually donned and conditioned through a series of tasks simulating clinical use. The third set was unstressed control gloves. The gloves from each set were water-leak tested and the results recorded. The durability method created defects in all areas of the gloves. The durability method produced defects at similar rates to the simulated clinical method for all the glove types tested. Defect rates correlated well with target defect rates established from the literature. Durability varied among glove types with powder-free vinyl being the least durable (42% defect rate) and powder-free, textured chloroprene the most durable (3% defect rate). The durability method was reproducible with a coefficient of variation of 2.4%. This method can be used to establish the durability of medical examination gloves of a variety of materials.