BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇻🇳 Vietnam

    POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED

    K Number: K170094 · Decision Jun 23, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    4
    Review Days
    163

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    Basic Information

    Device Name
    POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED
    K Number
    K170094
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Vietglove Corporation
    Date Received
    January 11, 2017
    Decision Date
    June 23, 2017
    Product Code
    LYY
    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
    LYY Latex Patient Examination Glove

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    Other Clearances by Vietglove Corporation

    K Number Device Name
    K201428 Powder Free Black Nitrile Examination Glove
    K162175 Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less
    K153562 Powder Free Blue Nitrile Examination Glove