BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇳 China

    SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVES

    K Number: K012104 · Decision Aug 21, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    4
    Review Days
    47

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    Basic Information

    Device Name
    SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVES
    K Number
    K012104
    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
    Beijing Reagent Latex Products Co., Ltd.
    Date Received
    July 5, 2001
    Decision Date
    August 21, 2001
    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 Beijing Reagent Latex Products Co., Ltd.

    K Number Device Name
    K211515 Nitrile Examination Gloves
    K062797 POWDERED LATEX SURGICAL GLOVE
    K010947 SNOW LOTUS POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)