BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇼 Taiwan

    MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES

    K Number: K063757 · Decision Jul 27, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    8
    Review Days
    220

    Basic Information

    Device Name
    MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES
    K Number
    K063757
    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
    Shanghai Motex Healthcare Co., Ltd.
    Date Received
    December 19, 2006
    Decision Date
    July 27, 2007
    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 Shanghai Motex Healthcare Co., Ltd.

    K Number Device Name
    K123126 MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532)
    K132802 MOTEX POWDERED NITRILE SURGICAL GLOVES
    K122557 MOTEX POWDER-FREE NITRILE SURGICAL GLOVES
    K041276 POWDER-FREE NITRILE EXAMINATION GLOVES
    K030207 NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735
    K020837 MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE
    K013261 MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE