Due to the increasing demand for nonlatex medical gloves in the health-care community, there is a need to assess the durability of alternative glove materials. This study examines durability characteristics of various glove materials by abrasion resistance testing. Natural rubber latex (latex), polyvinyl chloride (vinyl), acrylonitrile butadiene (nitrile), polychloroprene (neoprene), and a styrene-ethylene/butylene-styrene block copolymer (SEBS) were tested. All test specimens, with the exception of the vinyl, were obtained from surgical gloves. Unaged out-of-the-box specimens as well as those subjected to various degrees of artificial aging were included in the study. After the abrasion sequence, the barrier integrity of the material was assessed through the use of a static leak test. Other traditional tests performed on these materials were viral penetration to validate the abrasion data and tear testing for comparative purposes. The results indicate that specific glove-material performance is dependent upon the particular test under consideration. Most notably, abrasion, even in controlled nonsevere conditions, may compromise to varying degrees the barrier integrity of latex, vinyl, SEBS, nitrile, and neoprene glove materials. However, as evidenced by the results of testing three brands of neoprene gloves, the abrasion resistance of any one glove material may be significantly affected by variations in production processes.

Barrier integrity of unaged and oven-aged (at 70 degrees C) natural rubber latex examination gloves was assessed with a biaxial flex-fatigue method where failure was detected electronically, and by live viral penetration testing performed according to a modified version of ASTM F1671-97a. When no change in barrier properties was detected during flex testing, no virus passage was found after viral challenge. Conversely, when a change in the barrier properties was indicated by the electrical signal, virus passage was found in 74% of the specimens. Flex-fatigue results indicated that unaged test specimens from powdered (PD) and powder-free (PF) nonchlorinated gloves had significantly longer fatigue lives than powder-free chlorinated (CL) gloves from the same manufacturer. Biaxial flexing of oven-aged glove specimens showed a marginal increase in fatigue life for the PF gloves, but no increase for the PD gloves. The fatigue life of the CL gloves was observed to increase significantly after oven aging. However, this appears to be due to a design feature of the test apparatus, wherein peak volume displacement of the worked specimen is held constant. An aging-induced change in the viscoelastic properties of the CL gloves-permanent deformation of the specimens early in the fatigue test-relieves the stress magnitude applied as the test progresses. Thus, permanent deformation acts as a confounding factor in measuring durability of latex gloves by fixed displacement flex-fatigue.

The Food and Drug Administration received complaints of Huber needles creating cores in the septa of ports of gastric banding devices. One of these complaints represented a cluster of similar events, even though no deviations from design specifications or recommended practices were subsequently identified by the manufacturer. The authors conducted this comparative investigation of off-the-shelf Huber needles and ports from several manufacturers to determine if engineering parameters could be identified that could account for the coring complaints. Huber needles from ten manufacturers were evaluated for coring using intravascular access ports from five manufacturers. A detailed optical analysis was also performed to identify needle features that would possibly account for coring. The majority of the tested needles performed as they should, i.e., they perforated the port septa without creating cores. However, needles that did produce cores were found to have sharp edges at the heel edge of the needle lumen, the edge of the ground bevel opposite from the needle tip that opens to the inner surface of the cannula tube. Manufacturing processes, which dulled or rounded the sharp heel of the bevel after bevel grinding, prevented coring. As a result of this investigation one manufacturer voluntarily recalled their product and another manufacturer implemented coring testing as part of their quality control. To prevent coring needles from entering the market as a result of manufacturing flaws, optical inspection of the heel edge and coring testing should be performed as part of routine quality control.