FDA 510(k) Applications Submitted by LIM KWEE SHYAN

FDA 510(k) Number Submission Date Device Name Applicant
K213993 12/21/2021 Powder Free Chloroprene Examination Glove Coloured (Blue, Green) Careglove Global SDN BHD
K220859 03/24/2022 Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black) Careglove Global SDN BHD
K102902 09/30/2010 RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR RUBBERCARE PROTECTION PRODUCTS SDN BHD
K142858 10/01/2014 POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored) Careplus (M) SDN BHD
K103661 12/16/2010 RUBBERCARE POWDER FREE NITRILE EXAMINATION GLOVE RUBBERCARE PROTECTION PRODUCTS SDN BHD
K230121 01/17/2023 Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) Careglove Global SDN. BHD.
K190241 02/06/2019 Sterile Latex Surgical Glove, Powder Free Careglove Global 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
K172015 07/03/2017 POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED) Careglove Global Sdn Bhd
K161833 07/05/2016 LATEX EXAMINATION GLOVE POWDER FREE CAREGLOVE GLOBAL 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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