Relief For Latex Allergy Sufferers As FDA Clears New Medical Glove

Most allergies are easy to cope with by simply avoiding the trigger. Sometimes that’s easier said than done, such as in the case of a latex allergy. Estimates vary, but anywhere from 3 percent to 22 percent of all health care workers are sensitized to traditional latex.

For those in the healthcare profession, as well as patients who suffer from a latex allergy, every day there are materials that must be handled or avoided with caution, or suffer the consequences, ranging from a mild rash, to, worst-case scenario, anaphylactic shock.

Traditional latex gloves are made from the milky sap of a rubber tree, Hevea braziliensis. That sap contains a protein that can trigger allergic reactions, particularly after prolonged and repeated contact. Allergic reactions run the gamut from skin redness, rash, hives, or itching, to respiratory symptoms such as difficulty breathing, coughing spells and wheezing, and, rarely, shock.

Health care workers first began using traditional latex gloves in the 1890s. The HIV epidemic of the 80s ushered in modifications in glove materials, which made them more sensitizing to those with latex allergies.

Some health care institutions responded by shifting to alternative glove materials for their workers. The U.S. Food and Drug Administration (FDA) also implemented numerous steps to address the glove allergy problem, including working with the industry to develop a consensus standard that identifies maximum protein and powder levels for medical gloves. In addition, a 1998 rule requires that all medical devices containing latex carry a statement on the label warning about the risk of allergic reactions.

Most recently, FDA cleared for marketing the first device made from a new form of natural rubber latex called guayule latex. The product, the Yulex Patient Examination Glove, is derived from the guayule bush, a desert plant native to the Southwestern United States. The new material provides flexibility and strength comparable to latex.

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. Because there is no data on people’s long-term experience with the Yulex glove, which is made by the Yulex Corporation of Maricopa, Ariz., the product will carry a warning (for now) about the potential for allergic reactions.

Products such as the Yulex glove, which utilize new materials in inventive ways, are a benefit to both healthcare workers and patients. To get the FDA stamp of approval, companies such as VCI LLC can help. VCI specializes in compliance services that meet FDA standards, as well as expertise in validation, production, quality, and R&D. VCI also offers manufacturers a proactive approach to getting it right the first time--before a product even hits the shelf--thus negating the need for a reactive response down the road.

Call (734) 274-4680 or email us at Ask VCI to find out how VCI can help you.

Alternatively, call Dr. Norm Howe, Sr. Partner, directly at 734.740.9924