The U.S. Food and Drug Administration (FDA) 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.
"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."
American Dental Association (ADA) 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 about hand hygiene and glove use, as well as skin care and lotion use with latex gloves.
"Some dental health care workers have developed hypersensitivity to proteins derived from natural rubber latex used in certain medical and dental devices, including examination and surgical gloves," according to an ada.org notice on personal protective equipment (PPE). "These workers should use PPE made of an alternative material." Patients are encouraged to advise the dental office staff "if [they] have had a prior allergic reaction to latex-containing objects."
The FDA-approved product, the Yulex Patient Examination Glove, is derived from the guayule (pronounced "why-you-lee") bush, a desert plant native to the Southwest. The Yulex Corp., Maricopa, Ariz., noted in a news 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.
A material safety data sheet posted at the company’s Web site says guayule latex does not contain the tropical latex proteins that are present in natural rubber latex. The company describes guayule latex as "the natural solution to latex allergy."
Jeffrey Martin, Yulex president and chief executive officer, said the FDA action constitutes approval of a new technology that "essentially clears the path for other device manufacturers, medical and dental, to move forward. We are currently working with the specific companies that make the gloves. We will not manufacture them ourselves."
Manufacturers of patient examination gloves using this technology must file their own requests for FDA approval, Mr. Martin said. FDA reviews the premarket submission to determine if the product is at least as safe and effective as a legally marketed device. This is known as the premarket notification, or 510(k) process.
The FDA said its actions to address glove allergy problems include a rule requiring that all latex-containing medical devices carry a label warning of the risk of allergic reactions.
Available data on the new guayule latex show that people who are highly allergic to traditional latex do not react on first exposure to guayule latex proteins. However, because there are no data on long-term experience with the new glove, the product will carry a warning for now about the potential for allergic reactions, according to the April 23 FDA announcement.
