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

    Powder Free Vinyl Patient Examination Gloves (Yellow, White)

    K Number: K180260 · Decision Jun 12, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    7
    Review Days
    133

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    Basic Information

    Device Name
    Powder Free Vinyl Patient Examination Gloves (Yellow, White)
    K Number
    K180260
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shanxi Hongjin Plastic Technology Co., Ltd.
    Date Received
    January 30, 2018
    Decision Date
    June 12, 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 Shanxi Hongjin Plastic Technology Co., Ltd.

    K Number Device Name
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