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.
Traditional latex gloves are made from the milky sap of a rubber
tree, Hevea braziliensis. The sap contains a protein that may trigger
allergic reactions, especially after prolonged and repeated contact.
Sensitized people may experience mild reactions such as skin redness,
rash, hives, or itching. More severe reactions may include respiratory
symptoms such as difficulty breathing, coughing spells and wheezing.
Rarely, shock may occur.
Estimates vary, but anywhere from 3 percent to 22 percent of all
health care workers are sensitized 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.
"This approval has the potential to make a significant difference to
both the general public and the medical community at large," said
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. And yet they will not sacrifice the desirable properties of
traditional latex such as flexibility and strength."
Health care workers first began using traditional latex gloves in
the 1890s. But concerns about allergic reactions increased in the late
1980s after modifications in glove materials made them more sensitizing
just as glove use was soaring in response to the HIV epidemic. Some
health care institutions have since responded by shifting to
alternative glove materials for their workers.
FDA 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 (http://www.fda.gov/cdrh/dsma/fr93097.html).
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.
The Yulex glove is made by the Yulex Corporation of Maricopa, Ariz.
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FOR IMMEDIATE RELEASE
April 23, 2008
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Media
Inquiries:
Karen Riley, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
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