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

    mCare® Powder Free Nitrile Black Examination Glove

    K Number: K192444 · Decision Dec 31, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    7
    Review Days
    116

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    Basic Information

    Device Name
    mCare® Powder Free Nitrile Black Examination Glove
    K Number
    K192444
    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
    September 6, 2019
    Decision Date
    December 31, 2019
    Product Code
    LZA
    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
    LZA Polymer Patient Examination Glove

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    Other Clearances by Mercator Medical (Thailand), Ltd.

    K Number Device Name
    K251141 Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
    K213548 Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy
    K200967 mCare(R) Powder Free Nitrile Orange Examination Gloves
    K190876 mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed
    K172930 mCare Powder-free Blue Nitrile Examination Gloves
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