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

    POWDER FREE VINYL PATIENT EXAMINATION GLOVES

    K Number: K102099 · Decision Oct 6, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    5
    Review Days
    71

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    Basic Information

    Device Name
    POWDER FREE VINYL PATIENT EXAMINATION GLOVES
    K Number
    K102099
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hong DI Plastic Products Co., Ltd.
    Date Received
    July 27, 2010
    Decision Date
    October 6, 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 Hong DI Plastic Products Co., Ltd.

    K Number Device Name
    K102098 POWDER FREE VINYL PATIENT EXAMINATION GLOVES
    K101132 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (BLUE, WHITE, PINK)
    K070188 POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW
    K070187 POWDER FREE VINYL PATIENT EXAMINATION GLOVE