New Latex Glove Approved by FDA
A new latex glove, the Yulex Patient Examination Glove, was approved by the Food and Drug Administration. This is the first glove to procure approval that is manufactured from natural rubber latex, guayule latex. The news was posted by the FDA on the agency’s website.
This glove is intended to be used when examining patients who have an allergy to traditional latex gloves. Those are manufactured with milky sap derived from rubber trees, Hevea braziliensis. A protein is within the sap that can cause patients to develop an allergic reaction, which is more likely to occur after repeated or prolonged contact.
The material for the glove is derived from the guayule bush.This is a desert plant which is native to southwestern United States. Patients exposed to the new gloves did not develop an allergic reaction with the first exposure, even people with known severe latex allergies. There has yet to be sufficient time or data to assess long-term reactions to the gloves. As such, the gloves carry a warning about the potential for allergic reactions.
It is estimated that between 3 and 22 percent of healthcare workers have an allergy to traditional latex. Symptoms associated with an allergic reaction include itching, hives, rash, difficulty breathing, and some people rarely develop shock.
The FDA notes that the Yulex gloves provide an alternative for individuals who have latex allergy. The difference in manufacturing materials does not diminish the glove function.
April 28, 2008 Related topics: Product Approval & Certification, New Technology & Innovation, Hygiene & Cleanliness