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Consumer Update |
On April 23, 2008, the Food and Drug Administration (FDA) cleared for marketing the Yulex Patient Examination Glove. This is the first medical device made from guayule latex, a new form of natural rubber latex.
The Yulex glove is made from latex that is derived from the guayule bush, a desert plant native to the southwestern United States. Gloves made from guayule latex may prove to be a safer alternative for some people with sensitivity to traditional latex.
Traditional latex gloves are made from the milky sap of a rubber tree. The sap contains a protein that may trigger allergic reactions in some people, especially after prolonged and repeated contact.
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. Because there is no data on people’s long-term experience with the Yulex glove, made by the Yulex Corporation of Maricopa, Ariz., the product will carry a warning for now about the potential for allergic reactions.
Mild reactions may include 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.
The agency has taken many steps, including working with industry to develop a 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.
FDA Press Release
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01822.html
FDA Rule: Natural Rubber-Containing Medical Devices
http://www.fda.gov/cdrh/dsma/fr93097.html
Date Posted: April 25, 2008
