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 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.
To learn more about Yulex Corporation, visit http://www.yulex.com.
ABOUT YULEX CORPORATION
A renewable and sustainable enterprise, Yulex Corporation applies intelligent crop science and proprietary clean technology to create biobased medical products from guayule (why-YOU-lee), a plant native to the North American high desert and now an international industrial crop. Yulex(R) natural rubber provides medical device manufacturers with a natural rubber that is naturally free of the allergens associated with Type I Latex Allergy. Through Yulex Corporation's innovations, a new industry producing natural rubber, green fuel and non-toxic adhesives is born. For more, visit http://www.yulex.com.
|SOURCE Yulex Corporation|
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