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Hartalega Sdn Bhd

Dispositifs autorisés FDA 510(k) et PMA — 17 produits

Nombre total de dispositifs17
Catégories0
Dernière décision de la FDA
TypeNuméroNom du dispositifCodeDateActions
510(k) K201748 Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy DrugsKGO2020-10-02 Voir
510(k) K201531 Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)LZA2020-08-05 Voir
510(k) K200897 Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)KGO2020-06-01 Voir
510(k) K180645 Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)LZA2018-11-16 Voir
510(k) K180786 Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended CuffLZA2018-11-02 Voir
510(k) K173509 Biodegradable Nitrile Powder Free Examination Glove (Blue)LZA2018-08-17 Voir
510(k) K180644 Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon GreenLZA2018-08-10 Voir
510(k) K180505 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)LZA2018-06-14 Voir
510(k) K173137 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)LZA2017-12-12 Voir
510(k) K171874 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue)LZA2017-10-12 Voir
510(k) K170152 POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)KGO2017-05-05 Voir
510(k) K162491 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)LZA2017-02-08 Voir
510(k) K162819 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy DrugsLZA2017-01-09 Voir
510(k) K162818 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)LZA2017-01-09 Voir
510(k) K160560 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)LZA2016-08-04 Voir
510(k) K161006 Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of GloveLYY2016-08-04 Voir
510(k) K161008 POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVEKGO2016-07-28 Voir
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