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

    NATURAL RUBBER LATEX SURGEONS GLOVE

    K Number: K944053 · Decision Apr 25, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    4
    Review Days
    249

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    Basic Information

    Device Name
    NATURAL RUBBER LATEX SURGEONS GLOVE
    K Number
    K944053
    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
    Arent Fox
    Date Received
    August 19, 1994
    Decision Date
    April 25, 1995
    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 Arent Fox

    K Number Device Name
    K945843 SAFETY PLUS
    K945583 OCUSYSTEM(ART)
    K944054 POWDER FREE SURGEON'S GLOVE