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..
FDA 510(k) Cleared Powder-free Polychloroprene Patient Examination Glove Devices (Product Code OPC)
About Product Code OPC - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code OPC since 2021, with 1 receiving FDA clearance (average review time: 57 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
OPC devices are reviewed by the General Hospital panel. Browse all General Hospital devices →