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

    POWDERED VINYL EXAMINATION GLOVES

    K Number: K122176 · Decision Apr 11, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    2
    Review Days
    627

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    Basic Information

    Device Name
    POWDERED VINYL EXAMINATION GLOVES
    K Number
    K122176
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shu Tong Xinghua Co., Ltd.
    Date Received
    July 23, 2012
    Decision Date
    April 11, 2014
    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 Shu Tong Xinghua Co., Ltd.

    K Number Device Name
    K122377 POWDER FREE VINYL EXAMINATION GLOVES