FDA Bans Powdered Gloves

For the first time in 33 years, the FDA is banning a medical device. The ban, which is effective on Jan. 19, covers all powdered medical gloves except powdered radiographic protection gloves.

The FDA says powdered medical gloves pose "an unreasonable and substantial health risk" to healthcare workers and their patients. Powdered gloves are linked to several issues including breathing problems, wound inflammation, and post-surgical adhesions. The cost associated with these adverse events is estimated to fall between $26.8 million and $31.8 million each year.

FDA officials believe the ban will have little economic impact while healthcare providers make the move to non-powdered gloves.

Opponents of the ban say powdered gloves offer “superior tactile sense” and pose less of a risk now than before since manufacturers have reduced the amount of powder used.

An FDA ban on a medical device is extremely rare. Not since June 1983, when it banned prosthetic hair fibers, has the FDA banned a medical device.

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