FDA Bans Powdered Medical Gloves
Based upon an extensive review of the current benefits and risks of powdered glove use in surgical and other applications, the FDA has decided to ban their use and sale. This decision will have effects across a wide range of hospital and clinical settings, requiring rapid replacement with non-powdered gloves in the new year.
“In aggregate, the risks of powdered gloves include severe airway inflammation, hypersensitivity reactions (including asthma), allergic rhinitis, conjunctivitis, dyspnea, as well as granuloma and adhesion formation when exposed to internal tissue,” FDA Docket No. FDA–2015–N–5017 states. This ban is intended to reduce these risks, providing an estimated net public health benefit of up to $31.8 million annually.
Despite the many risks, the only benefit associated with powdered gloves was determined to be easier application and removal as well as slightly enhanced comfort. These benefits were found to be strongly outweighed by the numerous health risks to both patients and medical professionals. The ban, proposed on March 22, 2016, was confirmed on December 19, 2016, and will come into effect on January 18, 2017.
All powdered surgical and examination gloves (as well as powder for lubrication of medical gloves) currently stocked in manufacturing facilities, hospitals, clinics and any other location are required to be disposed of as dictated by local solid waste management protocols. The FDA has concluded that this will not significantly impact the environment.
This ban does not apply to powdered gloves for use in food preparation, or for those used for protection during radiography. The ban does not apply to other medical devices, such as condoms, and does not apply to non-powdered gloves that use powder during the manufacturing process.
Non-powdered gloves must have no more than 2 milligrams of powder per glove in the final product, as per the FDA’s 2008 Medical Glove Guidance Manual. The FDA will reclassify the descriptions of surgical and examination gloves in regulatory documents to include only non-powdered gloves.
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