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

    Disposable Synthetic Vinyl Nitrile Examination Glove

    K Number: K211354 · Decision Aug 8, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    11
    Review Days
    97

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    Basic Information

    Device Name
    Disposable Synthetic Vinyl Nitrile Examination Glove
    K Number
    K211354
    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 Cureguard Glove Co., Ltd.
    Date Received
    May 3, 2021
    Decision Date
    August 8, 2021
    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 Jiangsu Cureguard Glove Co., Ltd.

    K Number Device Name
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    K210691 Disposable Nitrile Medical Examination Glove
    K210684 Disposable Nitrile Medical Examination Glove
    K093576 RUBBER-LIKE POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR
    K081657 POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW)
    K081655 POWDER FREE VINYL PATIENT EXAMINATION GLOVES (LIGHT YELLOW)
    K070076 POWDER FREE VINYL PATINET EXAMINATION GLOVES, CLEAR (NON-COLORED)
    K070075 POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
    Search all 11 clearances from Jiangsu Cureguard Glove Co., Ltd. →