FDA rule delay limits info on latex gloves

New test identifies sensitizing protein

While a Food and Drug Administration (FDA) content labeling standard remains mired in the federal bureaucracy, glove purchasers aren’t getting the newly available information on protein content that could help reduce new sensitivities.

The American Society for Testing and Materials (ASTM) has developed a test for antigenic protein, the kind most likely to trigger sensitivity. The ASTM also has set voluntary standards for antigenic protein (10 mcg per dm2) and total protein (200 mcg per dm2). Powder-free gloves tend to be significantly below the standard, with a level of total protein as low as 50 mcg per dm2.

Under current federal regulations, manufacturers can state that they comply with the ASTM standards but cannot label the boxes with the level of antigenic and total protein. The proposed rule sets maximum allowable protein levels of 1,200 mcg per dm2 and requires labeling of protein content. Some manufacturers are testing for antigenic protein, others only are testing for total protein, says Kok-kee Hon, chairman of the ASTM D-11.40 Subcommittee on Consumer Rubber products.

"What the FDA doesn’t have is the rule that they must label it on the box," he says. The best bet for glove consumers: Ask the manufacturer for a certificate identifying the total extractable proteins and the antigenic protein level, Hon says.

The labeling rule is still moving forward, with a review of the economic impact analysis, says Mel Stratmeyer, PhD, chief of the Health Services Branch in the Center for Devices and Radiological Health in White Oak, MD. The FDA first proposed a latex glove labeling rule in 1999.

The FDA previously had projected that protein levels would continue to decline with labeling of protein content. Now, new tests will encourage manufacturers to reduce the proteins that cause sensitivity or trigger allergic reactions, explains Stratmeyer.

"We’ve gone from looking at total protein to an antigenic protein test," he says. "To narrow down the problem even more, you would go to the allergenic protein."

Glove manufacturers in Malaysia have developed the most sophisticated technology to remove proteins, says Hon.

What is the bottom line for hospitals as they consider purchasing latex gloves?

Powder-free gloves continue to be the safest choice, and they also have the lowest protein levels, glove experts say. Using latex gloves with low levels of antigenic protein greatly reduces the risk of new sensitivities among health care workers, says Denise Korniewicz, DNSc, RN, FAAN, professor, associate dean for research and doctoral programs and director of the Center of Nursing Research at the University of Miami School of Nursing.

And those gloves are easy to find. "Most manufacturers have already decreased different kinds of protein that cause reactions," says Korniewicz, who conducts glove research and also is on the faculty of the University of Miami School of Medicine. "Most gloves on the market are safe to use."

If someone has a latex allergy, he or she may
be able to work in an environment where other health care workers wear powder-free, low-allergen gloves. However, "just because the allergen proteins have been leached out to make it a low allergen content, I’m not sure that necessarily means you can wear a latex glove again," adds Korniewicz.

While research indicates that powder-free, low-allergen latex gloves have a low risk of causing a reaction in allergic individuals, hospitals should provide alternatives, she says.

Going latex-free may not resolve all issues of glove sensitivity, because some health care workers are sensitive to the chemical accelerants used to manufacture nitrile gloves, Korniewicz notes.

"We don’t have a perfect glove yet," she says. "I don’t think I could make a recommendation that they totally replace all their gloves with this one kind of glove."

One day, manufacturers may find a way to create gloves that don’t trigger latex allergies, predicts Hon. With a test for allergenic protein, which is still under development, "maybe they can reduce [the proteins] until no more allergen is there and create safe gloves one day," he says.