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

    DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES

    K Number: K033723 · Decision Feb 24, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    4
    Review Days
    90

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    Basic Information

    Device Name
    DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES
    K Number
    K033723
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Baoding Guanzhong Glove Co., Ltd.
    Date Received
    November 26, 2003
    Decision Date
    February 24, 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 Baoding Guanzhong Glove Co., Ltd.

    K Number Device Name
    K062714 SYNTHETIC VINYL PATIENT EXAM GLOVES, PRE-POWDERED, YELLOW
    K062715 SYNTHETIC VINYL PATIENT EXAM GLOVES POWDER-FREE, YELLOW
    K052006 POWDER-FREE VINYL EXAM GLOVES