Alert: FDA banned powdered gloves December 19, 2016

The US Food and Drug Administration (FDA) on Friday issued a final rule banning powdered medical gloves beginning on 19 January 2017.

FDA proposed the ban in March, citing mounting evidence that such gloves posed serious risks to patients, including airway and wound inflammation, post-surgical adhesions and allergic reactions.

This is only the second time FDA has banned a medical device since banning prosthetic hair fibers in 1983. In April, FDA proposed banning a third type of device, electrical stimulation devices when used to treat self-injurious or aggressive behavior, though a final ban is still pending.

“This ban is about protecting patients and health care professionals from a danger they might not even be aware of,” said Jeffrey Shuren, director of the Center for Devices and Radiological Health, after the ban was proposed.

Powdered Gloves Ban

Specifically, FDA says it will ban the sale, distribution and manufacturing of all powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder used to lubricate surgeon’s gloves, though it notes the ban will not apply to powdered radiographic protection gloves.

Additionally, the ban will not apply to powder used during the manufacturing process for non-powdered gloves, so long as only trace amounts (no more than 2mg of powder per glove) make it into the finished product.

For more information, please see the FDA order titled:  Banned Devices; Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove which can be found at the following URL:  https://www.federalregister.gov/documents/2016/12/19/2016-30382/banned-devices-powdered-surgeons-gloves-powdered-patient-examination-gloves-and-absorbable-powder