The Food and Drug Administration (FDA) issued the final rule to ban powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove due to the unreasonable and substantial risk to healthcare providers, patients, and others.
Powdered gloves are associated with a long list of potentially serious adverse events, including severe airway inflammation, hypersensitivity reactions, allergic reactions (including asthma), lung inflammation and damage, or post-surgical bands of fibrous scar tissue that form between internal organs and tissues. Aerosolized glove powder can also carry proteins that may cause respiratory allergic reactions.
In March 2016, the FDA proposed the ban on most powdered gloves in the United States. They described the risk of illness or injury to healthcare providers, patients, and others who are exposed as those that “cannot be corrected through new or updated labeling.” The proposed ban did not apply towards powdered radiographic protection gloves, non-powdered surgeon gloves, or non-powdered patient examination gloves.
Non-powdered alternatives for both surgeon’s and patient examination gloves are available and offer similar protection, dexterity and performance as powdered gloves. They do not carry the risks associated with glove powder.
The FDA stated that transitioning to alternatives in the marketplace “should not result in any detriment to public health.”
The final rule will be published in the Federal Regsister on December 19, 2016. The medical ban will be effective January 19, 2017.
For more information visit FederalRegister.gov.