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

    POWDERED VINYL PATIENT EXAMINATION GLOVES, YELLOW

    K Number: K070042 · Decision Feb 23, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    6
    Review Days
    51

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    Basic Information

    Device Name
    POWDERED VINYL PATIENT EXAMINATION GLOVES, YELLOW
    K Number
    K070042
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Super Safe Plastic Products Co., Ltd.
    Date Received
    January 3, 2007
    Decision Date
    February 23, 2007
    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 Super Safe Plastic Products Co., Ltd.

    K Number Device Name
    K070038 POWDER FREE VINYL PATIENT EXAMINATION GLOVE, YELLOW
    K070030 POWDER FREE VINYL PATIENT EXAMINATION GLOVE
    K070043 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE
    K070040 POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE
    K070035 POWDERED VINYL PATIENT EXAMINATION GLOVE