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

    STERILE NATURAL LATEX SURGICAL GLOVES

    K Number: K892108 · Decision Sep 8, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    556
    Applicant Total
    2
    Review Days
    158

    Basic Information

    Device Name
    STERILE NATURAL LATEX SURGICAL GLOVES
    K Number
    K892108
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    RUHN CHANG INDUSTRIAL CO., LTD.
    Date Received
    April 3, 1989
    Decision Date
    September 8, 1989
    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 RUHN CHANG INDUSTRIAL CO., LTD.

    K Number Device Name
    K891003 LATEX EXAMINATION GLOVES