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

    STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES

    K Number: K081464 · Decision Aug 28, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    32
    Review Days
    93

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    Basic Information

    Device Name
    STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES
    K Number
    K081464
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardinalhealth
    Date Received
    May 27, 2008
    Decision Date
    August 28, 2008
    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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