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FDA 510(k) & PMA Approved Dispositivos — 8 products

Total de dispositivos8
Categorias0
Última decisão da FDA
TipoNúmeroNome do dispositivoCódigoDataAções
510(k) K211621 Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)KGO2021-10-06 Ver
510(k) K203705 Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)LYY2021-08-20 Ver
510(k) K201857 Powder Free Nitrile Examination Glove Black and Dual Color White-BlueLZA2021-08-20 Ver
510(k) K210724 ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugsKGO2021-08-03 Ver
510(k) K210656 ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugsKGO2021-06-24 Ver
510(k) K202765 ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugsKGO2021-05-27 Ver
510(k) K162858 NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTESTLZC2017-07-24 Ver
510(k) K152593 LATEX EXAMINATION GLOVE POWDER FREELYY2016-02-25 Ver
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