BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇭 Thailand

    B-CARE POWDER FREE LATEX EXAMINATION GLOVES

    K Number: K051404 · Decision Sep 27, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    2
    Review Days
    119

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    Basic Information

    Device Name
    B-CARE POWDER FREE LATEX EXAMINATION GLOVES
    K Number
    K051404
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    B-Care Industries Co., Ltd.
    Date Received
    May 31, 2005
    Decision Date
    September 27, 2005
    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 B-Care Industries Co., Ltd.

    K Number Device Name
    K052845 B-CARE POWDERED LATEX EXAMINATION GLOVES