Surgical Tribune America

FDA bans most powdered gloves

By Surgical Tribune
January 09, 2017

SILVER SPRING, Md., USA: The Food and Drug Administration (FDA) has issued a final rule banning the use of most powdered medical gloves in the country. The rule, which goes into effect on Jan. 18, applies to patient examination gloves, powdered surgeons’ gloves and absorbable powder for lubricating surgeons’ gloves.

“While use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to them, which cannot be corrected through new or updated labeling,” the agency said when proposing the ban in March 2016.

In its summary of the rule, the FDA noted that the ban does not apply to powder used in the manufacturing process of nonpowdered gloves, where that powder is not intended to be part of the final finished glove. Furthermore, it stated that finished nonpowdered gloves are expected to include no more than trace amounts of residual powder from these processes and that the agency encourages manufacturers to ensure finished nonpowdered gloves have as little powder as possible.

The powder that is sometimes added to natural rubber latex gloves to make them easier to put on and take off can carry proteins that may cause respiratory allergic reactions, the FDA said. It explained that “although powdered synthetic gloves do not present the risk of allergic reactions, these devices are associated with an extensive list of potentially serious adverse events, including severe airway inflammation, wound inflammation, and post-surgical adhesions, which are bands of fibrous scar tissue that form between internal organs and tissues. These side effects have been attributed to the use of glove powder with all types of gloves.”

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