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

    TACTYLON TM SURGICAL GLOVE

    K Number: K902831 · Decision Jul 10, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    7
    Review Days
    12

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    Basic Information

    Device Name
    TACTYLON TM SURGICAL GLOVE
    K Number
    K902831
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Tactyl Technologies, Inc.
    Date Received
    June 28, 1990
    Decision Date
    July 10, 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 Tactyl Technologies, Inc.

    K Number Device Name
    K955464 TACTYLON POWDER FREE EXAMINATION GLOVE
    K955419 POWDER FREE TACTYLON SURGEONS GLOVE
    K953583 LUBRICATED CONDOM
    K950185 TACTYLON(TM) POWDER FREE SURGEONS GLOVE
    K911431 TACTYLON(TM) CONDOM
    K905109 PATIENT EXAMINATION GLOVE/HYPOALLERGENIC