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

    NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVES

    K Number: K983240 · Decision Nov 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    5
    Review Days
    76

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    Basic Information

    Device Name
    NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVES
    K Number
    K983240
    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
    Johnson & Johnson Medical, Div. of Ethicon, Inc.
    Date Received
    September 15, 1998
    Decision Date
    November 30, 1998
    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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    Other Clearances by Johnson & Johnson Medical, Div. of Ethicon, Inc.

    K Number Device Name
    K990236 MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT
    K990395 BARRIER SURGICAL GOWNS
    K983234 TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING
    K983394 MODIFICATION TO TIELLE HYDROPOLMER DRESSING