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

    SURGEON'S (SURGICAL) GLOVES

    K Number: K903534 · Decision Aug 17, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    3
    Review Days
    11

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    Basic Information

    Device Name
    SURGEON'S (SURGICAL) GLOVES
    K Number
    K903534
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Straitscom
    Date Received
    August 6, 1990
    Decision Date
    August 17, 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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    Other Clearances by Straitscom

    K Number Device Name
    K910009 HYPOALLERGENIC LATEX EXAMINATION GLOVES
    K885319 NON-STERILE EXAM GLOVES