FDA essentially banned all powdered medical gloves in the United States starting on Wednesday, January 18, 2017. On that date, not only are the gloves no longer allowed to be manufactured or distributed, but also healthcare providers must dispose of their stocks too. Everyone needs to be prepared to throw out all powdered medical gloves.
This action puts powdered medical gloves on the same level as prosthetic hair fibers – the only other banned device under FDA regulations.
What’s banned and what’s not banned?
FDA has banned three types of gloves:
(1) powdered surgeon’s gloves,
(2) powdered examination gloves, and
(3) absorbable powder for lubricating a surgeon’s glove.
The material of the glove is irrelevant; so the ban applies equally to both latex and nitrile gloves. However, the ban does not apply to radiographic protection gloves, and does not affect powder used in the manufacturing process where the finished glove only contains trace amounts of powder.
What activities are banned starting on January 18?
Everything. On January 18, powdered gloves are no longer permitted in the United States. This means no:
- manufacturing
- importing
- distributing
- using (including those in healthcare providers’ offices)
Thus, once the ban is in effect, the industry and the healthcare community have two options according to FDA: (1) destroy the gloves or (2) export them to a country that permits their use. Arguably, there is a third option: recondition the gloves so that they are no longer intended for medical use (such as janitorial gloves), which means that they are no longer subject to FDA’s regulation under the medical device definition.
How did we get here?
The medical community has long used powdered gloves in order to make taking on and off gloves easier and more comfortable. Starting in the 1990s, FDA began considering banning powdered medical gloves because they present a risk of airway inflammation, granulomas, and respiratory allergic reactions. However, FDA believed that the benefits outweighed the risks and did not propose banning the gloves at that time.
Starting in 2008, FDA renewed its interest in banning powdered medical gloves. This culminated in the March 2016 proposal to ban these gloves. FDA reasoned that glove technology had advanced sufficiently that viable alternatives exist so that powdered examination gloves now present an unreasonable and substantial risk, and that this risk cannot be corrected or eliminated through labeling.
Now what?
At this point, industry members and the healthcare community need to review their inventory to determine if they have any of the banned gloves. If so, they need to develop a strategy to dispose use of these gloves. This is because on January 18, they all become adulterated. Contact us today to learn more about the regulations on medical gloves.
