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

    HPI ORTHO SURGEONS' GLOVE

    K Number: K894828 · Decision May 7, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    6
    Review Days
    280

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    Basic Information

    Device Name
    HPI ORTHO SURGEONS' GLOVE
    K Number
    K894828
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Tillotson Rubber Co., Inc.
    Date Received
    July 31, 1989
    Decision Date
    May 7, 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 Tillotson Rubber Co., Inc.

    K Number Device Name
    K905765 PILGRIM NITRILE LATEX GLOVES (VARIOUS TYPES)
    K903756 STERILE PATIENT EXAMINATION GLOVES
    K903607 POWDER FREE, NON-STERILE EXAMINATION GLOVES
    K780181 GLOVES, FLOOR
    K770704 GLOVES, SURGEONS, LATEX