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
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
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