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

    POWDER FREE VINYL PATIENT EXAMINATION GLOVE

    K Number: K070037 · Decision Feb 20, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    6
    Review Days
    48

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    Basic Information

    Device Name
    POWDER FREE VINYL PATIENT EXAMINATION GLOVE
    K Number
    K070037
    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 Lianhe Shunda Plastic Products Co., L
    Date Received
    January 3, 2007
    Decision Date
    February 20, 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 Shijiazhuang Lianhe Shunda Plastic Products Co., L

    K Number Device Name
    K070041 POWDERED FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
    K070027 POWDERED (WHITE) VINYL PATIENT EXAMINATION
    K070026 POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
    K070046 POWDERED VINYL PATIENT GLOVE
    K070044 POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION