BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SYNTHETIC (BLUE) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE

    K Number: K042247 · Decision Sep 2, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    5
    Review Days
    14

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    Basic Information

    Device Name
    SYNTHETIC (BLUE) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE
    K Number
    K042247
    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 Hongxiang Plastics Products Co., Ltd.
    Date Received
    August 19, 2004
    Decision Date
    September 2, 2004
    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 Hongxiang Plastics Products Co., Ltd.

    K Number Device Name
    K053521 PRE-POWDERED STERILE VINYL GLOVE, CLEAR
    K053523 POWDER FREE STERILE VINYL GLOVE (CLEAR AND YELLOW)
    K992821 SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
    K992797 SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES