FDA clears glove made from new type of latex

The product, the Yulex Patient Examination Glove, is derived from the guayule bush, a desert plant native to the south western US.

Traditional latex gloves are made from the milky sap of a rubber tree, Hevea braziliensis, but this contains a protein that may trigger allergic reactions, especially after prolonged and repeated contact.

Mild reactions may occur, such as skin redness, rash, hives, or itching, but more severe reactions may include respiratory symptoms such as difficulty breathing, coughing spells and wheezing. Rarely, shock may occur. It is estimated that up to 22% of all healthcare workers are sensitised to traditional latex.

The examination gloves made with patented Yulex natural rubber, and given 510(k) clearance by the FDA, are naturally Hevea latex-free and do not contain proteins associated with allergic reactions to latex products from Hevea brasiliensis.

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 Yulex glove is made by the Yulex Corporation, of Maricopa, Arizona.

"We have worked closely with Hevea latex-sensitive individuals, the medical device industry, ASTM International and the FDA to bring this safe alternative to the marketplace," said Jeffrey Martin, president and ceo of Yulex Corporation. "We are pleased with the FDA's guidance and look forward to launching several other guayule-based products currently in the pipeline."

"With more hospitals becoming latex-safe and latex-free, Yulex natural rubber provides a safe alternative to both healthcare workers and patients who are sensitised to Hevea latex," said Dr Katrina Cornish, senior vice president of research and development at Yulex. While a scientist at the US Department of Agriculture – Agricultural Research Service (USDA-ARS) in the 1990s, Dr Cornish developed and patented the first process for producing guayule natural rubber for medical devices.

‘This approval has the potential to make a significant difference to both the general public and the medical community at large," said Dr Daniel Schultz, 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.’

In 2006, ASTM created a new latex category specifying, for the first time, safety standards based on protein content without lowering the performance standards to accommodate synthetic materials; Yulex natural rubber is the only material that meets the category's safety and performance requirements.

Since 1998 all medical devices containing latex must 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.