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

    VINYL CO-POLMER FREE EXAMINATION GLOVES, BLUE COLOR

    K Number: K092294 · Decision Oct 21, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    4
    Review Days
    84

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    Basic Information

    Device Name
    VINYL CO-POLMER FREE EXAMINATION GLOVES, BLUE COLOR
    K Number
    K092294
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bettercare Plastic Products Co., Ltd.
    Date Received
    July 29, 2009
    Decision Date
    October 21, 2009
    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 Bettercare Plastic Products Co., Ltd.

    K Number Device Name
    K092302 POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR
    K092301 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (YELLOW, WHITE, BLUE, PINK)
    K092296 POWDER FREE EXAMINATION GLOVE