RAPS, December 14, 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. (Read More)