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FDA Product Code

FDA Product Code OPC — Clearance Directory

Device Class
Class I
Assigned Panel
General Hospital
21 CFR Citation
880.6250

510(k) Clearances — 1 record

K-Number Device Name Applicant Decision Date Clearance Type Summary
K211758 Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) Hartalega NGC Sdn. Bhd. 2021-08-03 Traditional PDF ↗

Product code OPC · Class I · General Hospital. Data: openFDA.