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

    POWDER FREE NITRILE EXAMINATION GLOVES, BLUE

    K Number: K060147 · Decision Apr 28, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    2
    Review Days
    99

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    Basic Information

    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
    K Number
    K060147
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hongye Plastic Products Co., Ltd.
    Date Received
    January 19, 2006
    Decision Date
    April 28, 2006
    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 Hongye Plastic Products Co., Ltd.

    K Number Device Name
    K122408 POWDER FREE NITRILE EXAMINATION GLOVES (BLACK, WHITE, GREEN)