FDA provides 510(k) on examination gloves made from U.S.-sourced guayule
rubber that is naturally safe for people with Type I latex allergy
MARICOPA, Ariz., April 24 /PRNewswire/ -- 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.
"We have worked closely with Hevea latex-sensitive individuals, the medical device industry, ASTM International (ASTM) and the FDA to bring this safe alternative to the marketplace," says Jeffrey Martin, president and chief executive officer of Yulex Corporation. "We are pleased with the FDA's guidance and look forward to launching several other guayule-based products currently in the pipeline."
"With more hospitals becoming latex-safe and latex-free, Yulex natural rubber now provides a safe alternative to both healthcare workers and patients who are sensitized to Hevea latex," says Dr. Katrina Cornish, senior vice president of research and development at Yulex. While a scientist at the United States Department of Agriculture -- Agricultural Research Service (USDA-ARS) in the 1990s, Dr. Cornish developed and patented the first process for producing guayule natural rubber for medical devices.
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
|SOURCE Yulex Corporation|
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