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

    POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE

    K Number: K131440 · Decision Sep 25, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    5
    Review Days
    128

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    Basic Information

    Device Name
    POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
    K Number
    K131440
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hebei Hongsen Plastics Technology Co, Ltd.
    Date Received
    May 20, 2013
    Decision Date
    September 25, 2013
    Product Code
    LZA
    Advisory Committee
    General Hospital
    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
    LZA Polymer Patient Examination Glove

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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)
    K140988 POWDER FREE STERILE LATEX SURGICAL GLOVE, YELLOW COLOR (BRAND NAME: TITANFINE)