BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇲🇾 Malaysia

    Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)

    K Number: K211621 · Decision Oct 6, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    10
    Review Days
    133

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    Basic Information

    Device Name
    Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)
    K Number
    K211621
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Careplus (M) Sdn Bhd
    Date Received
    May 26, 2021
    Decision Date
    October 6, 2021
    Product Code
    KGO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KGO Surgeon'S Gloves

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    Other Clearances by Careplus (M) Sdn Bhd

    K Number Device Name
    K203705 Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)
    K201857 Powder Free Nitrile Examination Glove Black and Dual Color White-Blue
    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
    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
    K202765 ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs
    K162858 NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST
    K152593 LATEX EXAMINATION GLOVE POWDER FREE
    K142858 POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored)
    K142862 POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).