Powdered Medical Glove Ban Considered By FDA Due To Allergy Risks
Due to risks associated with powdered medical gloves, federal regulators have proposed a nationwide ban on their use.
The FDA published a federal register notice on Tuesday, outlining a new rule that would ban powdered gloves used in the medical profession.
According to the agency, the powder used on the gloves may cause enough latex exposure for medical professionals and patients to develop allergies that they may not have otherwise had.
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The proposed rule would make it illegal to market powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating surgeon’s gloves. The rule does not affect powdered radiographic gloves, none of which are currently on the market.
The FDA notes that the use of powdered medical gloves are already on the decline. However, the agency has determined that they pose an “unreasonable and substantial risk of illness or injury” to health care professionals, patients and anyone exposed to them. The FDA said the problem cannot be corrected with new or updated labels.
“This ban is about protecting patients and health care professionals from a danger they might not even be aware of,” Dr. Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, said in a press release. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”
The powder is used to make it easier to put on and remove the gloves. They come in either natural or synthetic versions.
According to the FDA, the natural aerosolized glove powder can carry proteins that cause respiratory allergic reactions. The synthetic powders, while they do not cause allergic reactions, can cause a number of potentially serious adverse events, including:
- Severe airway inflammation
- Wound inflammation
- Post-surgical adhesions
The proposed rule came as the result of a review of scientific literature and comments that followed a 2011 federal register notice. The FDA also noted that the removal of the gloves from the market would not cause a shortage, since there are non-powdered protective gloves available.
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