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

    Fusion Black Powder-Free Nitrile Exam Glove

    K Number: K150113 · Decision Jun 18, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    7
    Review Days
    149

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    Basic Information

    Device Name
    Fusion Black Powder-Free Nitrile Exam Glove
    K Number
    K150113
    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
    January 20, 2015
    Decision Date
    June 18, 2015
    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 Halyard Health

    K Number Device Name
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    K160709 HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves
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