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

    Vinyl Co-Polymer Powder Free Examination Gloves

    K Number: K142409 · Decision Dec 5, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    19
    Review Days
    100

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    Basic Information

    Device Name
    Vinyl Co-Polymer Powder Free Examination Gloves
    K Number
    K142409
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Grand Work Plastic Products Co., Ltd.
    Date Received
    August 27, 2014
    Decision Date
    December 5, 2014
    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 Grand Work Plastic Products Co., Ltd.

    K Number Device Name
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    K220250 Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
    K220240 Vinyl Co-Polymer Powder-free Examination Gloves, Black
    K102089 GRAND WORK PLASTIC PRODUCTS CO., LTD. POWDER FREE VINYL PATIENT EXAMINATION GLOVES
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