On December 19, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule (21 CFR Parts 878, 880, and 895) banning powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s gloves. According to the rule, FDA banned these products due to the fact that they present a substantial risk of illness or injury that cannot be corrected by eliminating or altering product labeling. Adverse events related to powdered gloves include:
- Severe airway inflammation
- Hypersensitivity reactions
- Allergic reactions
- Lung inflammation
- Damage to post-surgical adhesions
- Respiratory allergic reactions
The final rule becomes effective on January 19, 2017. The ban applies to all powdered gloves currently in commercial distribution, those already sold to consumers, and gloves intended to be distributed in the future. All banned gloves must be removed from the market by the effective date.
FDA defines a medical device ban as “a total prohibition on the current and future sales, distribution, and manufacturing of a medical device.” (21 USC 360f) FDA may analyze a device’s risks and benefits in many ways, including, but not limited to, evaluating medical literature, meeting with experts, or comparing the device to its alternatives. Only one other medical device has been banned by FDA since June 1983.
Registrar Corp is an FDA consulting firm that assists medical device companies with FDA regulations. Registrar Corp can help companies determine whether or not their products are banned under this final rule and review product claims for FDA compliance. For assistance with FDA regulations for medical gloves or other devices, contact Registrar Corp at +1-757-224-0177 or through our 24-hour Live Help chat service: http://www.registrarcorp.com/livehelp