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

    MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES

    K Number: K141042 · Decision Mar 19, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    7
    Review Days
    330

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    Basic Information

    Device Name
    MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES
    K Number
    K141042
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mercator Medical (Thailand), Ltd.
    Date Received
    April 23, 2014
    Decision Date
    March 19, 2015
    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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