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

    POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES

    K Number: K013998 · Decision Feb 13, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    6
    Review Days
    71

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    Basic Information

    Device Name
    POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES
    K Number
    K013998
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sheen More Ent. Co., Ltd.
    Date Received
    December 4, 2001
    Decision Date
    February 13, 2002
    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 Sheen More Ent. Co., Ltd.

    K Number Device Name
    K001637 DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR
    K001065 DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR
    K001155 DISPOSABLE POWDERED NITRILE EXAM GLOVE, WHITE COLOR
    K000226 DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR
    K992686 DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR