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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) K170794 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White)LZA2017-06-30 View
510(k) K162646 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)LZA2017-03-03 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 BLUELZA2017-02-06 View
510(k) K151997 Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)LZA2016-03-31 View

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