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

    B-CARE POWDERED LATEX EXAMINATION GLOVES

    K Number: K052845 · Decision Dec 16, 2005
    View on FDA
    Classifications
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    70

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    Basic Information

    Device Name
    B-CARE POWDERED LATEX EXAMINATION GLOVES
    K Number
    K052845
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    B-Care Industries Co., Ltd.
    Date Received
    October 7, 2005
    Decision Date
    December 16, 2005
    Product Code
    OPE
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

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    K Number Device Name
    K051404 B-CARE POWDER FREE LATEX EXAMINATION GLOVES