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

    POWDERED VINYL PATIENT EXAMINATION GLOVES

    K Number: K101341 · Decision Jun 14, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    2
    Review Days
    33

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    Basic Information

    Device Name
    POWDERED VINYL PATIENT EXAMINATION GLOVES
    K Number
    K101341
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shijiazhuang Universal Channel Plastic Co., Ltd.
    Date Received
    May 12, 2010
    Decision Date
    June 14, 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 Shijiazhuang Universal Channel Plastic Co., Ltd.

    K Number Device Name
    K100697 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)