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

    TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE

    K Number: K897192 · Decision Feb 15, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    505
    Review Days
    49

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    Basic Information

    Device Name
    TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE
    K Number
    K897192
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Baxter Healthcare Corp
    Date Received
    December 28, 1989
    Decision Date
    February 15, 1990
    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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