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

    Nitrile Examination Gloves

    K Number: K211515 · Decision Aug 24, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    4
    Review Days
    99

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    Basic Information

    Device Name
    Nitrile Examination Gloves
    K Number
    K211515
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beijing Reagent Latex Products Co., Ltd.
    Date Received
    May 17, 2021
    Decision Date
    August 24, 2021
    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 Beijing Reagent Latex Products Co., Ltd.

    K Number Device Name
    K062797 POWDERED LATEX SURGICAL GLOVE
    K012104 SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVES
    K010947 SNOW LOTUS POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)