OPC · Class I · 21 CFR 880.6250

FDA Product Code OPC: Powder-free Polychloroprene Patient Examination Glove

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.

Leading manufacturers include Hartalega NGC Sdn. Bhd..

1
Total
1
Cleared
57d
Avg days
2021
Since

List of Powder-free Polychloroprene Patient Examination Glove devices cleared through 510(k)

1 devices
1–1 of 1

How to use this database

This page lists all FDA 510(k) submissions for Powder-free Polychloroprene Patient Examination Glove devices (product code OPC). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the General Hospital FDA review panel. Browse all General Hospital devices →