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Hartalega NGC Sdn. Bhd.

FDA 510(k) & PMA Approved Devices — 21 products

Total Devices21
Categories3
Latest Approval2025-10-23
TypeNumberDevice NameCodeDate
510(k) K250861 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) LZA 2025-10-23 View
510(k) K251319 Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff LZA 2025-07-30 View
510(k) K243818 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) LZA 2025-01-08 View
510(k) K223437 Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) LZA 2023-05-17 View
510(k) K222225 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) LZA 2022-11-11 View
510(k) K221718 Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) KGO 2022-09-24 View
510(k) K214074 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 KGO 2022-05-26 View
510(k) K211758 Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) OPC 2021-08-03 View
510(k) K201772 Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) LZA 2020-08-25 View
510(k) K201530 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey) LZA 2020-08-05 View
510(k) K200581 Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) LZA 2020-04-25 View
510(k) K200019 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) LZA 2020-04-06 View
510(k) K192232 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) LZA 2019-11-08 View
510(k) K190454 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 LZA 2019-09-26 View
510(k) K183536 Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove KGO 2019-08-16 View
510(k) K183389 Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove KGO 2019-06-28 View
510(k) K172442 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) LZA 2017-11-06 View
510(k) K170794 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White) LZA 2017-06-30 View
510(k) K162646 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) LZA 2017-03-03 View
510(k) K162923 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 DRUGS - DARK BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK VIOLET BLUE LZA 2017-02-06 View
510(k) K151997 Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU) LZA 2016-03-31 View
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