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510(k) Data Aggregation

    K Number
    K213548
    Device Name
    Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy
    Date Cleared
    2022-02-21

    (105 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mercator Medical (Thailand) LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Nitrylex® Classic Powder Free Nitrile Blue Examination Gloves Tested for use with Chemotherapy Drugs are disposable devices intended for medical propose that are worn on the examiner's hands to prevent contamination between patent and examiner. The proposed device was tested for use with Chemotherapy Drugs as per ASTM D678-05 Standard Practice for Assessment Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drugs Permeation.
    Device Description
    Nitrylex® Classic Powder Free Nitrile Blue Examination Gloves Tested for use with Chemotherapy Drugs are disposable devices intended for medical propose that are worn on the examiner's hands to prevent contamination between patent and examiner.
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    K Number
    K200967
    Device Name
    mCare(R) Powder Free Nitrile Orange Examination Gloves
    Date Cleared
    2020-06-06

    (57 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mercator Medical (Thailand) LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    mCare® Powder Free Nitrile Orange Examination Gloves are disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    mCare® Powder Free Nitrile Orange Examination Gloves
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    K Number
    K192444
    Device Name
    mCare® Powder Free Nitrile Black Examination Glove
    Date Cleared
    2019-12-31

    (116 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mercator Medical (Thailand) LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    mCare® Powder Free Nitrile Black Examination Gloves are disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    mCare® Powder Free Nitrile Black Examination Glove
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    K Number
    K190876
    Device Name
    mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed
    Date Cleared
    2019-12-02

    (242 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mercator Medical (Thailand) LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    mCare® Powder Free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these chemotherapy gloves were tested for use with the following drug concentrations per ASTM D6978-05, The following drugs had no breakthrough detected up to 240 minutes - 1. Cisplatin, 1.0 mg/ml - 2. Cyclophosphamide (Cytoxan), 20 mg/ml - 3. Dacarbazine (DTIC), 10.0 mg/ml - 4. Doxorubicin Hydrochloride, 2.0 mg/ml - 5. Etoposide (Toposar), 20.0 mg/ml - 6. Fluorouracil, 50.0 mg/ml - 7. Methotrexate, 25 mg/ml - 8. Mitomycin C,0.5 mg/ml - 9. Paclitaxel (Taxol), 6.0 mg/ml - 10. Vincristine 1.0 mg/ml The following drugs showed breakthrough detected in less than 240 minutes: - 1. Carmustine (BCNU), 3.3 mg/ml: 24.6 minutes 2. Thiotepa (THT) 10.0 mg/ml: 68.9 minutes Warning-Not for Use with Carmustine and Thiotepa
    Device Description
    mCare® Powder-Free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.
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    K Number
    K172930
    Device Name
    mCare Powder-free Blue Nitrile Examination Gloves
    Date Cleared
    2018-04-13

    (200 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mercator Medical (Thailand) LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    mCare® Powder Free Nitrile Blue Examination Glove are disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    mCare® Powder-free Nitrile Blue Examination Gloves are substantially equivalent to the Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM Specification D 6319 -10, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.
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    K Number
    K141042
    Device Name
    MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES
    Date Cleared
    2015-03-19

    (330 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERCATOR MEDICAL (THAILAND) LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The mCare Powder Free Latex Examination Blue Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    mCare Powder Free Latex Examination Blue Glove
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