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

    Powder-Free Latex examination gloves

    K Number: K222612 · Decision Nov 25, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    169
    Registration Numbers
    169
    Same Product Code
    1953
    Applicant Total
    2
    Review Days
    87

    Basic Information

    Device Name
    Powder-Free Latex examination gloves
    K Number
    K222612
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangdong Kingfa Sci.&Tech. Co., Ltd.
    Date Received
    August 30, 2022
    Decision Date
    November 25, 2022
    Product Code
    LYY
    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
    LYY Latex Patient Examination Glove

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