FDA Medical Device Ban: Powdered Gloves

The Food and Drug Administration (FDA) published a final rule banning powdered gloves due to the unreasonable and substantial risk of illness or injury to individuals exposed to powdered gloves. Effective January 18, 2017, the medical device ban includes powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating surgeon’s gloves. This ban includes devices already in commercial distribution.

Medical device bans issued by the FDA prohibit the current and future sales, distribution, and manufacturing of the product; this is only the second medical device ban ever issued by the FDA.

Powdered gloves have been banned due to the risks posed to both patients and health care providers when internal body tissue is exposed to the powder. Exposure to the powder can result in severe airway inflammation and hypersensitivity reactions, and may trigger the body’s immune response which may lead to surgical complications. In addition, aerosolized powder on natural rubber latex gloves can carry latex proteins that have the potential to cause respiratory allergic reactions in the patient, wearer, or individuals in the area.

Due to surgical gloves being a common component of emergency preparedness stockpiles, please ensure that powdered glove types are not included in your jurisdiction’s stockpile due to the public health risk that is posed.

Questions or requests for further assistance concerning the powdered glove ban can be directed via email to Brooke Courtney or Michael Ryan.

About Anastasia Sonneman

Anastasia Sonneman serves as a Communications Specialist at NACCHO. Her work includes promoting local health departments’ best practices, as well as partner tools and resources, in environmental health, health and disability, and preparedness through NACCHO’s communications channels, storytelling, and outreach to various audiences.

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