OPC

Powder-Free Polychloroprene Patient Examination Glove

Product code

OPC

Device name

Powder-Free Polychloroprene Patient Examination Glove

Device class

Class 1

21 CFR

21 CFR 880.6250

Medical specialty

General Hospital

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).