FDA finalizes ban on powdered gloves

Beginning January 19, 2017, powdered medical gloves will be banned by the Food and Drug Administration (FDA), which cites “an unreasonable and substantial risk of illness or injury.”

The rule, first proposed in March, applies to powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating surgeon’s gloves. It doesn’t cover powdered radiographic protection gloves (which the FDA noted aren’t currently on the market) or gloves where powder is only involved in the manufacturing process and not the finished product.

The FDA moved ahead with the full ban because of the severity of complications from powdered risks. For example, aerosolized glove powder on natural rubber latex (NRL) gloves could cause a reaction to healthcare workers or patients with latex allergies. Powdered synthetic gloves, however, were associated with severe airway inflammation and adverse health events not related to surgery.

Those risks, the FDA said, couldn’t be mitigated with any label, but it expects few problems from removing the powdered gloves from hospitals and healthcare facilities.

“FDA believes that this ban would likely have minimal economic and shortage impact on the health care industry. Thus, a transition to alternatives in the marketplace should not result in any detriment to public health,” the regulation said.

Comments on the rule contained complaints about the difficulty of putting on non-powdered gloves—the FDA said the difference was “nominal” at best—and suggestions that non-powdered gloves inhibits “tactile sensations” needed to perform medical procedures, a claim the FDA dismissed.

Several requests were made to expand the ban to all natural rubber latex gloves.

“Unlike with powdered latex gloves, which have the ability to aerosolize glove powder and carry allergenic proteins, FDA believes the risk of allergic reaction to non-powdered NRL gloves, which affects the user and patients in direct contact with the glove, is adequately mitigated through already-required labeling that alerts users to this risk,” the regulation said.

The FDA also turned down requests to push back the effective date of the ban or allow companies to use powdered gloves until their inventory is depleted. Its regulation doesn’t expect much of a negative impact from throwing away unused gloves, but did predict up to $31.8 million in net benefits annually from reducing adverse events caused by powdered gloves.