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

    PATIENT EXAMINATION GLOES

    K Number: K102840 · Decision Feb 18, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    3
    Review Days
    142

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    Basic Information

    Device Name
    PATIENT EXAMINATION GLOES
    K Number
    K102840
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thai Hua Holding Co., Ltd.
    Date Received
    September 29, 2010
    Decision Date
    February 18, 2011
    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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    Other Clearances by Thai Hua Holding Co., Ltd.

    K Number Device Name
    K102846 PATIENT EXAMINATION GLOVES
    K102838 PATIENT EXAMINATION GLOVES