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

    HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves

    K Number: K160709 · Decision Sep 6, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    78
    Applicant Total
    7
    Review Days
    176

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    Basic Information

    Device Name
    HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves
    K Number
    K160709
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Halyard Health
    Date Received
    March 14, 2016
    Decision Date
    September 6, 2016
    Product Code
    LZC
    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
    LZC Medical Glove, Specialty

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