Biologist, U.S. Food and Drug Administration, Winchester Engineering & Analytical Center, Winchester, MA
University of New Hampshire, Durham, NH
(Received 23 March 2001; accepted 25 May 2001)
Natural rubber latex proteins are recognized as a cause of Type I (Immediate Type Hypersensitivity) reaction in some individuals who have been exposed to latex devices. Residual former-release, stripping, and/or donning powders have been found to carry these allergenic proteins into the air during handling and use. Exposure to airborne glove powder contaminated with latex allergens is known to provoke respiratory allergic symptoms in latex-sensitized individuals and may make it difficult for these individuals to continue working in jobs involving such exposure. The Food and Drug Administration has proposed a maximum level of 120 mg of donning powder/particulates per glove on powdered gloves. A survey was conducted to determine current powder levels on commercially available powdered latex patient examination gloves and surgeons' gloves. Ninety-seven samples of powdered latex medical gloves representing 32 different brands produced by foreign and domestic manufacturers for the U.S. market were evaluated for residual powders per glove by ASTM D 6124-00, Standard Test Method for Residual Powder on Medical Gloves. Powder levels ranged from 37 to 260 mg per glove for patient examination gloves and 30 to 513 mg per glove for surgeons' gloves. Of the gloves tested, 55.7% met the new maximum powder guidelines.
Paper ID: JTE12404J