FDA Clears First Medical Product Made From Yulex(R) Natural Rubber 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.
 
     (Photo: http://www.newscom.com/cgi-bin/prnh/20080424/LATH031)
 
     "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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