The agency has a proposal to ban most powdered medical gloves to protect patients and healthcare professionals.

Brian Buntz

On March 21, FDA announced a plan to ban the majority of powdered gloves in the United States stating "they pose an unreasonable and substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to them."

The move would apply to powdered surgeon's gloves and examination gloves, which are regulated as Class I-medical devices.

One of the dangers of powdered gloves--at least in natural rubber latex gloves--is that the powder can become aerosolized and trigger allergic reactions.

Powdered synthetic gloves are also not without risk. While they do not have the same risk of causing allergic reactions, they can cause a number of other adverse events such as severe airway inflammation, wound inflammation, and post-surgical adhesions, according to FDA. "These side effects have been attributed to the use of glove powder with all types of gloves," FDA explained in a statement.

Cornstarch, one of the most common powders for gloves, has been linked to adverse events when used on natural rubber latex gloves. These problems include everything from allergies and latex hypersensitivity, skin inflammation, transmission of infection, impaired wound healing and respiratory problems.

To reach its decision, the agency states that it weighed considerable evidence, including reviewing a large amount of scientific literature while also doing an economic analysis and determining that a potential ban would have a minimal impact on medical practice.

The ban would not pertain to powdered radiographic protection gloves because the agency says it believes there are none on the market.

Under the proposal, non-powered surgeon gloves and patient examination gloves would remain on the market and would be regulated as Class I-medical devices.

The proposal is available online at www.regulations.gov and is open to public comment for 90 days.

Many studies over the past two decades have found that powdered gloves could be dangerous, prompting some medical professionals and organizations to lobby for a ban.

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