The U.S Food and Drug Administration has proposed a ban on most of the powdered medical gloves in use throughout the country, claiming they pose a risk of illness or injury to healthcare providers, patients and others individuals who are exposed to them.
The proposed ban applies to powdered surgeon's gloves and examination gloves, and the absorbable powder for lubricating the gloves. The FDA said that new or updated labeling would not correct the issue.
Jeffrey Shuren, MD, director of FDA's Center for Devices and Radiological Health, said in a statement that the ban is about protecting patients and healthcare professionals from a danger they might not even be aware of. "We take bans very seriously and only take this action when we feel it's necessary to protect the public health," he said.
The FDA claims that the powdered gloves are dangerous for a variety of reasons. In particular, aerosolized glove powder on natural rubber latex gloves -- but not on synthetic powdered gloves -- can carry proteins that may cause respiratory allergic reactions. Although the synthetic gloves do not present the risk of allergic reactions, they're associated with an extensive list of potentially serious adverse events, including severe airway inflammation, wound inflammation, and post-surgical adhesions, which are bands of fibrous scar tissue that form between internal organs and tissues. These side effects have been attributed to the use of glove powder with all types of gloves.
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If finalized, the proposal to ban the products would ultimately remove them from the marketplace completely.
The FDA said it considered all available evidence, including a review of the available scientific literature and comments received on a February 2011 Federal Register Notice. The organization also conducted an economic analysis that showed a powdered glove ban would not cause a glove shortage, and the economic impact of a ban would not be significant. The ban is also not likely to impact medical practice, the FDA said, because many non-powdered protective glove options are currently available.