The Food and Drug Administration (FDA) has proposed a ban on most powdered gloves in the United States, which pose unreasonable risks of illness or injury to healthcare providers, patients, and others exposed to them. The ban would apply to powdered surgeon’s gloves, powdered examination gloves, and absorbable powder for lubricating surgeon’s gloves.
“This ban is about protecting patients and healthcare professionals from a danger they might not even be aware of,” said Jeffrey Shuren, MD, director of the 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.”
Powder sometimes is added to gloves to make it easier to put them on and take them off. But aerosolized glove powder on natural rubber latex gloves can carry proteins that may cause respiratory allergic reactions. And while powdered synthetic gloves don’t present allergic risks, they are associated with severe airway inflammation and post-surgical adhesions, or bands of fibrous scar tissue that form between internal organs and tissues.
The FDA believes these risks can’t be corrected through new or updated labeling, so it is moving forward with its proposal to ban these products. This decision comes after considering evidence including a thorough review of available scientific literature and comments received on a February 2011 Federal Register Notice.
Also, the FDA’s economic analysis concluded that a ban would not cause a glove shortage, nor would it impact medical practices because many nonpowdered options are available. In fact, the FDA notes that the use of these gloves already has been decreasing, and the ban would ultimately remove them from the market. The proposed rule is available at regulations.gov for public comment for the next 90 days.
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