FDA approves material for examination glove
The Food and Drug Administration (FDA) has cleared for marketing a device made from a new form of natural rubber latex, guayule latex. The Yulex Patient Examination Glove, made by Maricopa, AZ-based Yulex, is derived from the guayule bush, a desert plant native to the southwestern United States.
Available data on the guayule latex show that even 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," said Daniel Schultz, MD, director of the 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."
Because there are 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. The gloves' manufacturer has not yet been named.