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

    SURGEON'S GLOVES

    K Number: K974356 · Decision Jan 29, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    5
    Review Days
    71

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    Basic Information

    Device Name
    SURGEON'S GLOVES
    K Number
    K974356
    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
    American Health Products, Inc.
    Date Received
    November 19, 1997
    Decision Date
    January 29, 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 American Health Products, Inc.

    K Number Device Name
    K923967 PATIENT EXAM GLOVES (POWDER FREE)
    K892291 PATIENT EXAM GLOVES (MFG. AMERICAN RUBBER PRODUCT)
    K892292 PATIENT EXAM GLOVES (MFG. MULTI-COM SDN BHD)
    K874148 MONITRON SYSTEM