FDA bans powdered surgeon’s and patient examination gloves

The US Food and Drug Administration is banning powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove after determining that these devices carry a substantial risk of illness or injury.

Although healthcare professionals use medical gloves to prevent against the transmission of infectious diseases and contaminants when conducting surgery or during interactions with patients, the FDA found that the use of powder on medical gloves presents numerous health risks, including inflammation, granulomas, and respiratory allergic reactions.

“FDA has carefully evaluated the risks and benefits of powdered gloves and the risks and benefits of the state of the art, which includes viable non-powdered alternatives that do not carry any of the risks associated with glove powder, and has determined that the risk of illness or injury posed by powdered gloves is unreasonable and substantial,” the FDA stated in their final ruling.

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

The FDA notes that the ban does not apply to powder used in the manufacturing process of non-powdered gloves, and finished non-powdered gloves should include no more than trace amounts of residual powder from these processes. The agency recommends that non-powdered gloves have no more than 2 mg of residual powder and debris per glove, as stated in the FDA’s 2008 Medical Glove Guidance Manual.

The ban is expected to reduce the number of adverse events associated with the use of powdered gloves, and the agency estimates the total annual net benefit to range between $26.8 million and $31.8 million.

The FDA’s final ruling is effective January 18, 2017, and will apply to devices already in commercial distribution, devices already sold to users, and to any devices that would be sold or distributed in the future.

Reference

1. US Food and Drug Administration. Banned devices; powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s gloves. Published December 19, 2016. Accessed December 20, 2016.