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

    Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)

    K Number: K182043 · Decision Sep 21, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    7
    Review Days
    53

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    Basic Information

    Device Name
    Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)
    K Number
    K182043
    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 Titans Hongsen Medical Technology Co., Ltd.
    Date Received
    July 30, 2018
    Decision Date
    September 21, 2018
    Product Code
    LYZ
    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
    LYZ Vinyl Patient Examination Glove

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    Other Clearances by Hebei Titans Hongsen Medical Technology Co., Ltd.

    K Number Device Name
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    K212097 Disposable medical surgical mask
    K211229 Vinyl compound examination gloves
    K181130 Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs