In a rare move, the Food and Drug Administration (FDA) announced on Friday that it is banning the following devices after determining that they present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling:
- Powdered surgeon's gloves (21 CFR 878.4460)
- Powdered patient examination gloves (21 CFR 880.6250)
- Absorbable powder for lubricating a surgeon's gloves (21 CFR 878.4480)
The ban will apply to products already in commercial distribution and already sold to ultimate users. Devices must be removed from the market by the rule's effective date, January 18, 2017.
After reviewing currently available information, the FDA concluded that the unreasonable and substantial risks of using these products outweigh their public health benefit. The risks the FDA cited include:
- Health care worker and patient sensitization to natural rubber latex allergens
- Surgical complications related to peritoneal adhesions
- Severe airway inflammation
- Hypersensitivity reactions
- Allergic reactions
- Allergic rhinitis
When compared to these risks, the FDA found the benefits associated with powdered gloves, which include greater ease of donning and doffing, decreased tackiness and added comfort, to be nominal. According to the FDA, this disparity, together with the availability of non-powdered alternatives that provide similar protection, meet the standard necessary to justify the ban on the devices.
In support of its determination that labeling is insufficient to mitigate the risks presented by continued use of these products, the FDA discussed the spread of powder inherent with use, the fact that powder-transported contaminants such as natural rubber latex allergens can become aerosolized and the fact that persons, other than the individual who wears the gloves, such as patients, are exposed to the potential dangers without the opportunity to consider the device labeling.
What the ban does not cover
The ban does not cover: i) powder used in the manufacturing process of non-powdered gloves, although, the FDA noted that finished non-powdered gloves should include no more than trace amounts of residual powder, which the FDA recommends as two milligrams or less; or ii) powder intended for use in or on other medical devices, such as condoms. In addition, manufacturers will still be able to export existing inventory of powdered gloves to foreign countries if the devices comply with the countries' laws, and are authorized to be marketed by the appropriate regulatory agencies of those countries.
In connection with the ban, the FDA will amend the descriptions of surgeon's gloves and patient examination gloves in the regulations to include only non-powdered versions of the devices and will add the powdered versions and the absorbable power to the listing of banned devices (21 CFR part 895).
The FDA has banned only one other medical device, prosthetic hair fibers, in 1983.