FDA clears new latex-free glove
06/01/2008
The U.S. Food and Drug Administration (FDA) has cleared for marketing the Yulex® patient examination glove, which is made from a form of natural rubber latex derived from the guayule bush. Guayule rubber does not contain proteins associated with allergic reactions to latex products from Hevea brasiliensis, the source of traditional latex rubber, according to the Yulex manufacturer, Yulex Corp. of Maricopa, AZ.
As a result of several Type I latex allergy deaths, FDA initiated strict regulations of all products made with the Hevea rubber latex, including warning labels about the risk of allergic reaction on products containing latex. The U.S. Department of Agriculture??Agricultural Research Service (USDA-ARS) subsequently began research to identify a safer domestic source for latex. Dr. Katrina Cornish, senior vice president of R&D at Yulex Corp., developed and patented the first process for producing guayule natural rubber from the native desert plant for medical devices while a scientist at USDA-ARS in the “90s. Yulex Corp. licensed the basic technology from USDA-ARS, established guayule as an industrial crop, and developed technologies for commercial production of the new rubber material.
Yulex Corp. president and CEO Jeffrey Martin says that the company has worked closely with Hevea latex-sensitive individuals, the medical device industry, ASTM, and the FDA to bring about the development of the new glove. The company reports that the Yulex rubber is the only material that meets the 2006 ASTM latex safety standards requiring no detectable Hevea antigenic protein.
FDA says that anywhere from 3 percent to 22 percent of all health care workers are sensitized to traditional latex, which can cause reactions ranging from mild skin irritation and hives to severe respiratory symptoms and even death. Available date on the new guayule latex show that people who are highly allergic to traditional latex do not react on first exposure to guayule latex proteins.
“This approval has the potential to make a significant difference to both the general public and the medical community at large,” says Daniel Schultz, M.D., director of FDA’s Center for Devices and Radiological Health. “Gloves made from guayule latex may prove to be a safer alternative for some people with sensitivity to traditional latex,” without sacrificing flexibility and strength.
Currently there is no long-term data on reactions with the Yulex glove; for the time being, the product will carry a warning about the potential for allergic reactions.