US FDA Approves for Marketing a New Natural Rubber Latex for Dental Gloves and Dams

Dr. Katrina Cornish examines Guayule seedlings while at USDA

From the American Dental Association: FDA issues market clearance for new form of latex glove

The U.S. Food and Drug Administration cleared for marketing a patient examination glove made from a new form of natural rubber latex, the first approval of a device derived from a desert plant native to the Southwestern United States. The FDA regulates medical-dental devices.

“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.”

American Dental Association latex allergy notices for the profession and patients are posted at www.ada.org under Oral Health Topics. The ADA Web site also includes information on hand hygiene and glove use and skin care and lotion use with latex gloves. “Some dental healthcare workers have developed hypersensitivity to proteins derived from natural rubber latex used in certain medical and dental devices, including examination and surgical gloves,” says an ada.org notice on personal protective equipment. “These workers should use PPE made of an alternative material.” Patients are encouraged to advise the dental office staff “if you have had a prior allergic reaction to latex-containing objects.”

The FDA-approved product, the Yulex Patient Examination Glove, is derived from the guayule bush, a desert plant native to the Southwest. The Yulex Corp., Maricopa, Ariz., said in a press release that examination gloves made with patented Yulex natural rubber, and cleared by the FDA, do not contain proteins associated with allergic reactions to latex products. Traditional latex gloves are made from the milky sap of a rubber tree.

Flap has been fortunate that he has never experienced (first hand – sorry for the bad pun) a latex allergy to gloves. But, I have seen it for others, including dentists, assistants, hygienists and patients. The use of other glove substitutes do not provide the snugness of fit like latex.

Flap is looking forward to the distribution of this product. But, will they be able to ramp up production to satisfy demand?

The website for the Yulex Corporation is here.