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

    VINYL EXAMINATION GLOVE, POWDER FREE, NON-COLORED

    K Number: K093264 · Decision May 28, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    2
    Review Days
    221

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    Basic Information

    Device Name
    VINYL EXAMINATION GLOVE, POWDER FREE, NON-COLORED
    K Number
    K093264
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Qingdao Lang Hui Import & Export Co., Ltd.
    Date Received
    October 19, 2009
    Decision Date
    May 28, 2010
    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 Qingdao Lang Hui Import & Export Co., Ltd.

    K Number Device Name
    K093263 STRETCH VINYL EXAMINATION GLOVE, POWDER FREE, YELLOW/WHITE