Powder is often added to medical gloves in an effort to make them easier to put on and take off, but aerosolized glove powder on latex gloves can cause serious respiratory allergic reactions. Additionally, powdered synthetic gloves, although not associated with an increased risk of allergic reactions, pose several potential medical complications, including wound inflammation, airway inflammation, and post-surgical adhesions.
According to Jeffrey Shuren, M.D., director of FDA’s Center for Devices and Radiological Health:
“This ban is about protecting patients and health care 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.”
If approved, the ban will apply to powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for surgeon glove lubrication. The ban would not apply to powdered radiographic protection gloves, because the agency is not aware of any such gloves available on the market. Non-powdered surgeon gloves and non-powdered patient examination gloves would also be excluded from the ban.
Prior to the ban proposal, the FDA conducted a thorough review of scientific literature and comments received in response to a February 2011 public inquiry on the topic. The FDA also determined that the ban would be unlikely to impact medical practice due to the wide availability of similar, non-powdered gloves.
The proposed rule is available online for public comment for 90 days.