BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇳 China

    Disposable Sterilized Latex Surgical Gloves

    K Number: K211953 · Decision May 25, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    556
    Applicant Total
    3
    Review Days
    336

    Basic Information

    Device Name
    Disposable Sterilized Latex Surgical Gloves
    K Number
    K211953
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd
    Date Received
    June 23, 2021
    Decision Date
    May 25, 2022
    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 Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd

    K Number Device Name
    K214017 Examination gloves-Type A(Latex gloves)
    K212290 Examination gloves -Type C (Nitrile gloves)