FDA proposes to ban most powdered medical gloves


Because they pose health risks including respiratory allergic reactions and wound inflammation

The Food and Drug Administration is proposing to ban most powdered gloves in the US because they pose health risks to patients and healthcare workers.

Although powder is used to make it easier to put gloves on and take them off, the FDA says the powder added to some rubber latex gloves can carry proteins that may cause respiratory allergic reactions and are associated with potentially serious adverse events, including severe airway inflammation, wound inflammation, and scar tissue on internal organs when used during surgery.

The proposed ban, which will apply to powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove, is not expected to have much impact on glove supplies or manufacturer sales, according to government research. Most powdered gloves have already been phased out and their use is in decline, the FDA says.

'This ban is about protecting patients and healthcare professionals from a danger they might not even be aware of,' said Jeffrey Shuren, Director of the FDA’s Centre for Devices and Radiological Health.

The FDA says its proposal on surgical gloves is based on an extensive review of scientific literature and public comments received on a February 2011 Federal Register Notice.

The US regulator normally addresses safety issues with medical devices by adding warning labelling or modifying their instructions for use, but concluded that issues with powdered gloves could only be addressed by removing them from the market.

The FDA says the ban is not likely to have an impact on medical practice, because many non-powdered protective glove options are currently available.

The ban would not apply to powdered radiographic protection gloves. Non-powdered surgeon's gloves and non-powdered patient examination gloves will also not be included in the ban and will remain Class I medical devices.

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The FDA will take public comments on the proposal here for 90 days.