The Food and Drug Administration (FDA or Agency) has determined that Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. Consequently, FDA is banning these devices.
- Powdered Surgeon’s Gloves
- Powdered Patient Examination Gloves
- Absorbable Powder for Lubricating a Surgeon’s Glove
This rule is effective on January 18, 2017.
“The risk of illness or injury posed by powdered gloves is unreasonable and substantial,” the FDA said in issuing the ban. The agency cited potential consequences including inflammation, granulomas and respiratory allergic reactions.
The FDA, which is responsible for enforcing the ban, recommends that unused stocks of powdered gloves be thrown away as one would dispose of any typical solid waste. Specific consequences for failure to comply with the ban have not been publicized.
2D73TE80 $109.802D73TE80 $109.80