Important note: Information in this article was accurate in 1990. The state of the art may have changed since the publication date.
Food and Drug Administration, U.S. Department of Health and Human Services - December 12, 1990
Susan Cruzan - (301) 443-3285
Under current FDA requirements, manufacturers of medical gloves must have their own testing programs. Today's announcement will standardize the testing and define the maximum failure rate for the test.
FDA announced that it will examine randomly selected samples of manufacturers' gloves for tears, holes and any foreign matter embedded in the gloves as part of its inspection program.
FDA also will subject the gloves to a water leak test the agency has developed. In the test, 1,000 milliliters of water (about a quart) are poured into a glove, which is then checked for leaks.
Gloves will not be permitted to be sold for medical uses if leaks are found at rates greater than 25 per 1,000 for surgeons' gloves and 40 per 1,000 for patient examination gloves. The rate is lower for surgeons' gloves because they come in contact with internal areas of the body and may have longer periods of exposure to blood and other bodily fluids than do examination gloves.
Walter E. Gundaker, acting director of FDA's Center for Devices and Radiological Health, said, "Previous FDA surveys had shown that some batches of gloves had failure rates far in excess of the new limits, so our program should result in gloves that are far more reliable than in the past. The quality levels we have established are minimal requirements, which means that most glove batches will have lower failure rates.
"This program," he continued, "should help assure concerned health care workers that their gloves are adequate to do the job."
Foreign glove manufacturers may be placed on an import detention list if their gloves consistently do not meet the new FDA requirements. Domestic gloves which do not meet the requirements will be seized, if necessary, to keep them off the market.
The federal Centers for Disease Control in Atlanta recommends that doctors, dentists and other health care workers wear gloves for protection against diseases such as hepatitis B and AIDS. The use of protective gloves is widespread and, while CDC knows of 20 published cases of infection with HIV (the AIDS virus) among health workers occupationally, most involved accidents in which the workers were accidentally stuck by a needle.
Four of these reports of AIDS infection are associated with medical workers whose skin, thought to be chapped or scratched, was exposed to the virus.
FDA's regulation is in today's Federal Register. It will be effective 90 days after publication.
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SOURCE: Food and Drug Administration (FDA).
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