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

    BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

    K Number: K071414 · Decision Sep 10, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    556
    Applicant Total
    9
    Review Days
    112

    Basic Information

    Device Name
    BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
    K Number
    K071414
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MOLNLYCKE HEALTH CARE US, LLC
    Date Received
    May 21, 2007
    Decision Date
    September 10, 2007
    Product Code
    KGO
    Advisory Committee
    General, Plastic Surgery
    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
    KGO Surgeon'S Gloves

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