FDA ban on powdered examination gloves now in effect
The FDAFDA ban on powdered examination gloves is now in effect.
The FDA ban on powder for gloves is now in effect. The final ruling on the ban was issued on December 16, 2016 and was due to take effect on January 18, 2017.
The ban includes powdered surgeon's gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon's glove.
The FDA determined that these products “present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling.”
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A long review concucted by the FDA found multiple health risks associated with the use of powdered gloves. These include “health care worker and patient sensitization to natural rubber latex (NRL) allergens, surgical complications related to peritoneal adhesions and other adverse health events not necessarily related to surgery, such as inflammatory responses to glove powder.”
More specifically, the risks included “severe airway inflammation, hypersensitivity reactions, allergic reactions (including asthma), allergic rhinitis, conjunctivitis, dyspnea, as well as granuloma and adhesion formation when exposed to internal tissue.”
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It is important to note that the ban does not include a ban on powder used in the manufacturing process of powder-free gloves. Powder-free gloves are to have, according to FDA guidelines, no more than 2 milligrams of residual powder and debris per glove.
When studied, it was found that benefits of powdered gloves were few-it was easier to take them on and off, they decreased tackiness and added a small amount of comfort-and the benefits far outweighed the possible costs. This is especially true because there are already many alternatives to powdered gloves on the market.
The FDA believes that this ban will have a net positive impact. More and more manufacturers were switching to powder-free gloves before the ban went into effect, meaning there will be no large or long-term economic consequences. They believe the rule will be overwhelmingly positive, with estimates of a net gain between $26.8 million and $31.8 million annually.
The FDA bans medical devices very infrequently, having only banned one other device in the past-prosthetic hair fibers in 1983.
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