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

    Disposable Medical Nitrile Examination Gloves (Non sterile)

    K Number: K212639 · Decision Dec 8, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    78
    Applicant Total
    2
    Review Days
    110

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    Basic Information

    Device Name
    Disposable Medical Nitrile Examination Gloves (Non sterile)
    K Number
    K212639
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jiangsu Nanfang Medical Co., Ltd.
    Date Received
    August 20, 2021
    Decision Date
    December 8, 2021
    Product Code
    LZC
    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
    LZC Medical Glove, Specialty

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