FDA Seeks To Ban Most Powdered Medical Gloves

By Jof Enriquez,
Follow me on Twitter @jofenriq

The U.S. Food and Drug Administration (FDA) is proposing to ban powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove, due to mounting evidence that powder can cause harm.

Based on a review of available scientific literature and other information, FDA said that powder — added to gloves to make it easier to put them on and take them off — pose unreasonable and substantial risk to health providers and patients. Specifically, aerosolized glove powder on natural rubber latex gloves can cause respiratory allergic reactions, and powdered synthetic gloves can cause severe airway inflammation, wound inflammation, and post-surgical adhesions.

“This ban is about protecting patients and health care professionals from a danger they might not even be aware of,” said Jeffrey Shuren, M.D., director of FDA’s Center for Devices and Radiological Health (CDRH), in a statement. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”

If the ban were to be finalized, FDA plans to amend the descriptions of these devices that these new regulations would apply only to non-powdered gloves.

The proposed rule does not include powdered radiographic protection gloves, non-powdered surgeon gloves, and non-powdered patient examination gloves. FDA believes that residual powder used in the manufacturing process of finished non-powdered gloves, or powder used in or on other medical devices, such as condoms, do not pose a similar health risk, and thus they are not included in the proposed ban.

The agency considered banning powdered gloves back in 1997, after first knowing the risks they posed, but decided to hold off because it would have caused shortages and been disruptive to medical practice, according to the The New York Times.

Dr. Sidney M. Wolfe, a founder of consumer rights advocacy group Public Citizen, told NYT, "There's absolutely no reason that they could not have initiated the ban back in 1998", but added that doing so "would have created a shortage for a necessary medical device."

In its press release, FDA said an economic analysis revealed that removing most powdered gloves off the market now will no longer impact medical practice significantly, since many non-powdered protective glove options are currently available and many facilities have long switched over to non-powdered alternatives.

FDA will accept comments on the proposed rule until June 20, 2016.