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Hartalega NGC Sdn. Bhd.

FDA 510(k) & PMA Approved Devices — 24 products

Total Devices24
Categories3
Latest FDA decision2026-07-28
TypeNumberDevice NameCodeDateActions
510(k) K260558 Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl CitrateKGO2026-07-28 View
510(k) K254285 Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet BlueLZA2026-07-20 View
510(k) K260867 Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)LZA2026-06-17 View
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)LZA2025-10-23 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 CuffLZA2025-07-30 View
510(k) K243818 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)LZA2025-01-08 View
510(k) K223437 Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)LZA2023-05-17 View
510(k) K222225 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)LZA2022-11-11 View
510(k) K221718 Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)KGO2022-09-24 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 DrugsKGO2022-05-26 View
510(k) K211758 Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)OPC2021-08-03 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)LZA2020-08-25 View
510(k) K201530 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey)LZA2020-08-05 View
510(k) K200581 Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)LZA2020-04-25 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)LZA2020-04-06 View
510(k) K192232 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)LZA2019-11-08 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 CuffLZA2019-09-26 View
510(k) K183536 Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of GloveKGO2019-08-16 View
510(k) K183389 Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical UndergloveKGO2019-06-28 View
510(k) K172442 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)LZA2017-11-06 View

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