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

    CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES

    K Number: K935917 · Decision Feb 4, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    12
    Applicant Total
    632
    Review Days
    56

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    Basic Information

    Device Name
    CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES
    K Number
    K935917
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5570
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    December 10, 1993
    Decision Date
    February 4, 1994
    Product Code
    KGB
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KGB Mask, Oxygen, Non-Rebreathing

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