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

    Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color

    K Number: K171616 · Decision Jul 20, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    4
    Review Days
    49

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    Basic Information

    Device Name
    Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color
    K Number
    K171616
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shandong Xingyu Gloves Co., Ltd.
    Date Received
    June 1, 2017
    Decision Date
    July 20, 2017
    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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    Other Clearances by Shandong Xingyu Gloves Co., Ltd.

    K Number Device Name
    K233990 Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)
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