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The powdered latex gloves frequently used by physicians and health care providers may soon be on their way out should a recent proposed ban from the Food and Drug Administration be approved. In the proposed ban, the FDA identifies three types of surgical gloves that the ban would apply to including: (1) Powdered Surgeon’s Gloves, (2) Powdered Patient Examination Gloves, and (3) Absorbable Powder for Lubricating a Surgeon’s Glove.

When discussing the ban Jeff Shuren, M.D, the director of the FDA’s Center for Devices and Radiological Health, said “this ban is about protecting patients and health care professionals from a danger they might not even be aware of.” The FDA has identified that the underlying problem with these particular gloves stems from the powder used to line the gloves. Initially, the powder was added to the gloves to make it easier for physicians and health care providers to put on and take off the gloves. Yet, over time, this powder can generate an unintended effect, leaving patients at risk for injury.

Some may view the ban on gloves as a unnecessary and overly drastic step. Typically, when dealing with a device that generates unexpected risks, the FDA will add a warning label to the device or limit the way the device may be used instead of ban it. Yet, in this case, the FDA has found that these surgical gloves “present an unreasonable and substantial risk of illness or injury and that risk cannot be corrected or eliminated by labeling or a change in labeling.” As such, the FDA appears to believe a ban may be the most appropriate step. In a press announcement the FDA explained the “aerosolized glove powder on natural rubber latex gloves . . . can carry proteins that may cause respiratory allergic reactions.” Some of the dangers identified by the FDA associated with the use of powdered gloves include severe airway inflammation, severe respiratory allergic reactions, wound inflammation, and post-surgical adhesions.

The FDA has stated it does not anticipate that a ban on the powdered latex gloves will significantly impact the medical field because many non-powdered glove options are currently available. The proposed rule is available for public comment until June 20, 2016 at www.regulations.gov. Given the injuries generated by this powder, it appears that this ban is a step in the right direction to protect patients and physicians alike.

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