FDA 510(k) Applications Submitted by Careplus (M) SDN BHD

FDA 510(k) Number Submission Date Device Name Applicant
K142858 10/01/2014 POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored) Careplus (M) SDN BHD
K210656 03/04/2021 ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50╡g/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Pro Careplus (M) SDN BHD
K210724 03/10/2021 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 wit Careplus (M) SDN BHD
K211621 05/26/2021 Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) Careplus (M) SDN BHD
K201857 07/06/2020 Powder Free Nitrile Examination Glove Black and Dual Color White-Blue Careplus (M) SDN BHD
K152593 09/10/2015 LATEX EXAMINATION GLOVE POWDER FREE Careplus (M) SDN BHD
K202765 09/21/2020 ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs Careplus (M) SDN BHD
K142862 10/01/2014 POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). Careplus (M) SDN BHD
K162858 10/12/2016 NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST Careplus (M) SDN BHD
K203705 12/18/2020 Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) Careplus (M) SDN BHD


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