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

    POWER FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR

    K Number: K113191 · Decision Nov 17, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    4
    Review Days
    17

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    Basic Information

    Device Name
    POWER FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
    K Number
    K113191
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Suqian Ruijang Medical Supplies Co., Ltd.
    Date Received
    October 31, 2011
    Decision Date
    November 17, 2011
    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 Suqian Ruijang Medical Supplies Co., Ltd.

    K Number Device Name
    K113194 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR
    K113193 PATIENT EXAMINATION GLOVE
    K113195 POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)