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Hartalega Sdn Bhd

FDA 510(k) & PMA Approved Dispositivos — 17 products

Total de dispositivos17
Categorías0
Última decisión de la FDA
TipoNúmeroNombre del dispositivoCódigoFechaAcciones
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 Ver
510(k) K201531 Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)LZA2020-08-05 Ver
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 Ver
510(k) K180645 Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)LZA2018-11-16 Ver
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 Ver
510(k) K173509 Biodegradable Nitrile Powder Free Examination Glove (Blue)LZA2018-08-17 Ver
510(k) K180644 Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon GreenLZA2018-08-10 Ver
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 Ver
510(k) K173137 Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)LZA2017-12-12 Ver
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 Ver
510(k) K170152 POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)KGO2017-05-05 Ver
510(k) K162491 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)LZA2017-02-08 Ver
510(k) K162819 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy DrugsLZA2017-01-09 Ver
510(k) K162818 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)LZA2017-01-09 Ver
510(k) K160560 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)LZA2016-08-04 Ver
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 Ver
510(k) K161008 POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVEKGO2016-07-28 Ver
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