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

FDA 510(k) Number Submission Date Device Name Applicant
K183389 12/06/2018 Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove Hartalega NGC Sdn. Bhd.
K190454 02/25/2019 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue) - Extended Cuff Hartalega Ngc Sdn. Bhd.
K150110 01/20/2015 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin P HARTALEGA NGC SDN. BHD.
K200019 01/03/2020 Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black) Hartalega NGC Sdn. Bhd.
K200581 03/05/2020 Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Hartalega NGC SDN. BHD.
K170794 03/16/2017 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White) HARTALEGA NGC SDN. BHD.
K211758 06/07/2021 Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) Hartalega Ngc Sdn. Bhd.
K201530 06/08/2020 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey) Hartalega Ngc Sdn. Bhd.
K151684 06/22/2015 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue) HARTALEGA NGC SDN. BHD.
K201772 06/29/2020 Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Hartalega NGC Sdn. Bhd.
K222225 07/25/2022 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) Hartalega NGC Sdn. Bhd.
K172442 08/11/2017 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) Hartalega NGC SDN. BHD.
K192232 08/16/2019 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) Hartalega NGC Sdn. Bhd.
K162646 09/22/2016 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) HARTALEGA NGC SDN. BHD.
K162923 10/18/2016 NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DR HARTALEGA NGC SDN. BHD.
K223437 11/14/2022 Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) Hartalega NGC SDN. BHD.
K143419 11/28/2014 Patient Examination Gloves HARTALEGA NGC SDN. BHD.
K183536 12/19/2018 Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove Hartalega Ngc Sdn. Bhd.
K214074 12/27/2021 Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs Hartalega NGC SDN. BHD.
K140890 04/08/2014 NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU) HARTALEGA NGC SDN. BHD.
K140610 03/10/2014 NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU) HARTALEGA NGC SDN. BHD.


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