Ban on powdered gloves effective January 18
Adverse side effects have been attributed to the use of glove powder
FDA has made a move to ban powdered gloves worn by health care providers because of their “unreasonable and substantial” illness or injury risk to health care providers, patients, and other individuals.
The final rule from FDA states that all powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s gloves must be removed from the market by January 18, 2017.
According to language in the final rule, the ban applies to devices already in commercial distribution and those already sold to the ultimate user, as well as to devices that would be sold or distributed in the future.
Although fewer health care providers use these types of gloves, the risk cannot be corrected through new or updated labeling.
“The act of banning a device is an important decision, and the FDA only takes this action on rare occasions when necessary to protect the health of the public,” said Shannon Thor, PharmD, MS, from FDA’s Office of Health & Constituent Affairs, in a letter to stakeholders. The last time FDA banned a medical device was in 1983 with prosthetic hair fibers.
There are many dangers associated with powdered gloves. Aerosolized glove powder on natural rubber latex gloves—but not on synthetic powdered gloves—can carry proteins that may cause respiratory allergic reactions. Although powdered synthetic gloves do not present the risk of allergic reactions, these devices are associated with an extensive list of potentially serious adverse events, including severe airway inflammation, wound inflammation, and postsurgical adhesions. These adverse effects have been attributed to the use of glove powder with all types of gloves, according to FDA.
Powder is sometimes added to gloves to help make it easier to put them on and take them off but new technology in nonpowdered alternatives provides the same benefits—without the risks associated with glove powder.