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

    GLOVES, SURGEONS,MICRO-TOUCH POWDERFREE

    K Number: K770056 · Decision Feb 25, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    5
    Review Days
    45

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    Basic Information

    Device Name
    GLOVES, SURGEONS,MICRO-TOUCH POWDERFREE
    K Number
    K770056
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Arbrook Mfg. Corp.
    Date Received
    January 11, 1977
    Decision Date
    February 25, 1977
    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 Arbrook Mfg. Corp.

    K Number Device Name
    K792016 DISCARD-A-PAD 40-COUNT SHARPS DISPOSAL
    K781847 LATEX, IN-HOUSE COMPOUNDED
    K781278 GLOVES, PROCEDURE
    K760421 THERMOMETER, SURVALENT-ELECTRONIC