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

    DISPOSABLE POWDERED VINYL EXAM GLOVE, YELLOW COLOR

    K Number: K071122 · Decision Dec 12, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    8
    Review Days
    233

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    Basic Information

    Device Name
    DISPOSABLE POWDERED VINYL EXAM GLOVE, YELLOW COLOR
    K Number
    K071122
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xuzhou Full Sun Medical Products , Ltd.
    Date Received
    April 23, 2007
    Decision Date
    December 12, 2007
    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 Xuzhou Full Sun Medical Products , Ltd.

    K Number Device Name
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    K072377 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVE, WHITE COLOR
    K072314 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR
    K072472 DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED
    K072401 DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR
    K071123 DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR