Yulex Corporation, a company that produces natural rubber found to be safe for medical devices, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the first medical device made from guayule, a desert crop native to the U.S. Southwest.
The examination gloves made with patented Yulex(R) natural rubber, and cleared by the FDA, do not contain proteins associated with allergic reactions to latex products from Hevea brasiliensis, and are naturally Hevea latex-free.
After the AIDS crisis increased latex glove use dramatically in the 1980s, several Type I latex allergy deaths were reported due to the high amounts of residual Hevea protein contained in medical products. As a consequence, the FDA initiated strict regulatory requirements of all products made with Hevea natural rubber latex, and the USDA-ARS began conducting research and development to identify a safer, domestic source for latex. Yulex Corporation then licensed basic technology from the USDA-ARS, and, after years of development, Yulex established guayule as an industrial crop and developed the manufacturing technologies to produce guayule natural rubber commercially.
In 2006, ASTM created a new latex category specifying, for the first time, safety standards based on protein content without lowering the performance standards to accommodate synthetic materials, and Yulex natural rubber is the only material that meets the category’s safety and performance requirements.
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