FDA Proposes Ban on Most Powdered Surgical Gloves
On 21st March, 2016, the U.S. Food and Drug Administration (FDA) proposed banning most powdered gloves in the U.S. While the use of these gloves is on the decline, the risks associated with them for both healthcare workers and patients, cannot be corrected through new or updated labeling, says the FDA.
“This ban is about protecting patients and healthcare professionals from a danger they might not even be aware of,” says Jeffrey Shuren, M.D., director of FDA’s Center for Devices and Radiological Health. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”
The powder that is sometimes added to natural rubber latex gloves to aid in putting them on or taking them off, can carry proteins that might cause respiratory allergic reactions. Also, while powdered synthetic gloves don’t typically cause allergic reactions, they have been linked to potentially serious side effects such as severe airway inflammation, wound inflammation, and post-surgical adhesions. It’s important to note here that these side effects have been associated with powder used in gloves, regardless of the type of the glove used.
The ban would apply to powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s gloves. It does not extend to non-powdered surgeon and examination gloves. Those gloves will remain listed as Class I medical devices, which are devices that pose the least amount of risk to the patient or healthcare worker.
The public will be able to comment on the proposed rule online at www.regulations.gov for 90 days.