FDA 510(k) Applications for Medical Device Product Code "OPC"
(Powder-Free Polychloroprene Patient Examination Glove)

FDA 510(k) Number Applicant Device Name Decision Date
K211758 Hartalega Ngc Sdn. Bhd. Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) 08/03/2021


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