BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇳 China

    POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW)

    K Number: K081657 · Decision Aug 20, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    11
    Review Days
    69

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    Basic Information

    Device Name
    POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW)
    K Number
    K081657
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jiangsu Cureguard Glove Co., Ltd.
    Date Received
    June 12, 2008
    Decision Date
    August 20, 2008
    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 Jiangsu Cureguard Glove Co., Ltd.

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    K093576 RUBBER-LIKE POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR
    K081655 POWDER FREE VINYL PATIENT EXAMINATION GLOVES (LIGHT YELLOW)
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