On December 19, 2016, the Food and Drug Administration (FDA) announced its’ determination “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. This rule is effective on January 18, 2017.”
For further information, go to: Https://www.regulations.gov and insert FDA-2015-N-5017 into the search box and follow the prompts. Alternatively, you may contact the Division of Dockets Management 5630 Fishers Lane, Rm 1061, Rockville MD 20852.
In compliance with this determination, QRP has discontinued the sale of the following products:
- BQP09 – Qualatrile Blue 9″ Lightly Powdered Nitrile Gloves
- 8BQP09 – Qualatrile Blue 9″ Lightly Powdered 8 mil Nitrile Gloves
- 609BP – BioTek 9″ Lightly Powdered Latex Gloves
- 2C – Lightly Powdered Finger Cots