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

    BANTEX SURGICAL LATEX GLOVES- TYPE 1 NATURAL RUBBER LATEX SURGICSL GLOVES, STERILE

    K Number: K963218 · Decision Oct 30, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    5
    Review Days
    75

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    Basic Information

    Device Name
    BANTEX SURGICAL LATEX GLOVES- TYPE 1 NATURAL RUBBER LATEX SURGICSL GLOVES, STERILE
    K Number
    K963218
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    American Bantex Corp.
    Date Received
    August 16, 1996
    Decision Date
    October 30, 1996
    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 American Bantex Corp.

    K Number Device Name
    K042104 AMERICAN BANTEX, MODEL MS 3
    K041963 AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI
    K040754 AMERICAN BANTEX MS 4 MINI SCOOTER
    K031711 TANGO, MODELS, BP1