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

    POWDER FREE STERILE LATEX SURGICAL GLOVE, YELLOW COLOR (BRAND NAME: TITANFINE)

    K Number: K140988 · Decision Aug 12, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    5
    Review Days
    117

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    Basic Information

    Device Name
    POWDER FREE STERILE LATEX SURGICAL GLOVE, YELLOW COLOR (BRAND NAME: TITANFINE)
    K Number
    K140988
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hebei Hongsen Plastics Technology Co, Ltd.
    Date Received
    April 17, 2014
    Decision Date
    August 12, 2014
    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 Hebei Hongsen Plastics Technology Co, Ltd.

    K Number Device Name
    K163146 POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs
    K150340 POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue)
    K140989 POWDER FREE NITRILE SURGICAL GLOVES, WHITE COLOR (BRAND NAME: TITANFINE)
    K131440 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE