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Powder-Free Polychloroprene Patient Examination Glove

FDA product code OPC · 1 cleared devices

Class 1 General Hospital
Regulation
21 CFR 880.6250
Review panel
HO
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2021-08-03 – 2021-08-03

A powder free polychloroprene patient examination glove is a disposable device made of polychloroprene rubber tthat bears powder to facilitate donning, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

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