BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    POWDER-FREE NITRILE EXAMINATION GLOVES

    K Number: K041276 · Decision Aug 20, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    8
    Review Days
    100

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    Basic Information

    Device Name
    POWDER-FREE NITRILE EXAMINATION GLOVES
    K Number
    K041276
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shanghai Motex Healthcare Co., Ltd.
    Date Received
    May 12, 2004
    Decision Date
    August 20, 2004
    Product Code
    LZA
    Advisory Committee
    General Hospital
    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
    LZA Polymer Patient Examination Glove

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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
    K063757 MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL 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