ERJ staff report (DS)
Washington DC -- The U.S. Food and Drug Administration has cleared for marketing the first device made from a new form of natural rubber latex, guayule latex. The product, the Yulex Patient Examination Glove, is derived from the guayule bush, a desert plant native to the Southwestern United States.
"This approval has the potential to make a significant difference to both the general public and the medical community at large," said Daniel Schultz, MD, 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. And yet they will not sacrifice the desirable properties of traditional latex such as flexibility and strength."
In a statement,t he FDA said, "Estimates vary, but anywhere from 3 percent to 22 percent of all health care workers are sensitised to traditional latex. Available data on the new guayule latex show that even people who are highly allergic to traditional latex do not react on first exposure to guayule latex proteins."
The FDA said it has taken numerous steps to address the glove allergy problem including working with industry to develop a consensus standard that identifies maximum protein and powder levels for medical gloves. A 1998 rule requires that all medical devices containing latex carry a statement on the label warning about the risk of allergic reactions. Because there is no data on people's long-term experience with the Yulex glove, the product will carry a warning for now about the potential for allergic reactions.
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Press release from FDA