Healthcare Solutions 21 December, 2016

FDA Issues Ban on Powdered Gloves


Effective January 18th 2017, powdered gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s gloves will be banned by the Food and Drug Administration. These gloves present risk of illness or injury to healthcare providers and their patients.

While these items can be helpful in the right circumstance, they have been attributed to serious events such as severe airway inflammation, hypersensitivity reactions, allergic reactions (including asthma), lung inflammation and damage or post-surgical bands of fibrous scar tissue that form between internal organs and tissues (adhesions). The FDA has determined that the non-powdered alternatives provide similar protection and performance without the risk of illness or injury posed by the powdered gloves.

This is only the second time the FDA has banned a medical device. The first ban was on prosthetic hair fibers, in 1983.

Additional information can be found on the Federal Register or FDA Medical Device Bans Page.
 

Posted by Stericycle

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