FDA Bans Powdered Gloves

On December 16, 2016, the FDA displayed the final rule to ban powdered surgeon's gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon's glove because these products present unreasonable and substantial risk to health care providers, patients and other individuals.

While medical gloves play a significant role in protecting patients, health care providers and other individuals in close proximity, powdered gloves are very dangerous for a variety of reasons. These devices are associated with an extensive list of potentially serious adverse events, including 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). These adverse events have been attributed to the use of glove powder with all types of gloves. In addition, aerosolized glove powder can carry proteins that may cause respiratory allergic reactions.

The state of the art of both surgeon's and patient examination gloves includes non-powdered alternatives that provide similar protection, dexterity, and performance that powdered gloves do, but do not carry any of the risks associated with glove powder. Thus, a transition to alternatives in the marketplace should not result in any detriment to public health.
The act of banning a device is an important decision, and the FDA only takes this action on rare occasions when necessary to protect the health of the public. The FDA has only banned one other medical device, prosthetic hair fibers in June 1983.

For more information on Medical Device Bans, please visit the FDA’s Medical Device Ban webpage.

Published by the Food and Drug Administration, Center for Devices and Radiological Health

Reference: Download a copy of the 21 CFR Parts 878, 880, and 895: Banned Devices; Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove by clicking on the document title shown next to "Download Attachments", shown below.

Last modified on Friday, 30 December 2016 21:54
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