Gloves with new latex may be less allergenic

Rubber gloves made from guayule latex, which contain low level of protein and may improve to be less allergenic than traditional latex rubber gloves, were recently approved by the Food and Drug Administration.

Guayule latex is a new form of natural rubber latex derived from the guayule bush, a desert plant native to the southwestern United States. The gloves, regulated as a device, are the first device made from this form of latex, according to FDA.

The company that manufactured these gloves will not sell the gloves directly to hospitals; rather, it will sell the guayule rubber to medical device manufacturers that will make the products.

Despite data showing that even people who are highly allergic to traditional latex do not react the first time they are exposed to guayule latex proteins, there are no long-term data, so the product will have a warning about the potential for allergic reactions, according to FDA.

Guayule latex gloves may prove to be safer alternative for some people with sensitivity to traditional latex, and would provide flexibility, strength and other positive features of traditional latex gloves, the director of the FDA’s Center for Devices and Radiological Health said in the FDA statement announcing the approval. Traditional latex rubber gloves are made from the sap of the rubber tree Hevea braziliensis.

A unique property of guayule rubber is its very low protein content, even before the manufacturing process, explained by the professor of medicine and pathology at John Hopkins University, Baltimore. He is on the latex task force at John Hopkins Hospital, which has eliminated latex from the hospital and converted entirely to synthetic gloves because they don’t know what levels of allergenic protein, even in low levels that are now in the Hevea latex gloves being produced, can sensitize an individual.

An in vitro cross-reactivity study he and his associates conducted in the mid-1990s, before the Corporation was formed, showed that Hevea latex proteins do not cross-react with guayule protein. But before his institution would consider using guayule rubber gloves, a carefully controlled prospective study showing they are safe to use in people highly sensitized to Hevea latex is necessary. The doctor is planning such a study in adults with spina bifida who were sensitized to Hevea latex as children.

A potential application of guayule is for indwelling urinary catheters, for which elasticity is important.