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

    Disposable Medical Nitrile Examination Gloves (Non-sterile)

    K Number: K212600 · Decision Nov 18, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    444
    Registration Numbers
    445
    Same Product Code
    1158
    Applicant Total
    1
    Review Days
    93

    Basic Information

    Device Name
    Disposable Medical Nitrile Examination Gloves (Non-sterile)
    K Number
    K212600
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Suqian Linglian Medical Technology Co., Ltd
    Date Received
    August 17, 2021
    Decision Date
    November 18, 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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