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Careplus (M) Sdn Bhd

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

Total Devices8
Categories4
Latest Approval2021-10-06
TypeNumberDevice NameCodeDate
510(k) K211621 Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) KGO 2021-10-06 View
510(k) K203705 Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) LYY 2021-08-20 View
510(k) K201857 Powder Free Nitrile Examination Glove Black and Dual Color White-Blue LZA 2021-08-20 View
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 drugs KGO 2021-08-03 View
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 drugs KGO 2021-06-24 View
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 drugs KGO 2021-05-27 View
510(k) K162858 NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST LZC 2017-07-24 View
510(k) K152593 LATEX EXAMINATION GLOVE POWDER FREE LYY 2016-02-25 View