FDA 510(k) Applications Submitted by Hartalega NGC SDN BHD

FDA 510(k) Number Submission Date Device Name Applicant
K151343 05/19/2015 Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange) HARTALEGA NGC SDN BHD
K221718 06/13/2022 Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) Hartalega NGC SDN BHD
K151836 07/06/2015 NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK HARTALEGA NGC SDN BHD
K151997 07/20/2015 Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU) HARTALEGA NGC SDN BHD


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