DeviceClearance

Product code OPC— General Hospital

Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)

Classification name
Powder-Free Polychloroprene Patient Examination Glove
Device class
Class 1
Regulation
21 CFR 880.6250
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code OPC under 21 CFR 880.6250, via openFDA

Market context for product code OPC

FDA has cleared 1 device under product code OPC, all in 2021, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code OPC

Recent clearances under product code OPC

Data sourced from openFDA. This site is unofficial and independent of the FDA.