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510(k) Data Aggregation

    K Number
    K193121
    Device Name
    GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims
    Manufacturer
    ECO Medi Glove SDN BHD
    Date Cleared
    2020-03-20

    (129 days)

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

    ECO Medi Glove SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gen 2 Nitrile Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner. In addition these gloves was tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by Chemotherapy Drugs.
    Device Description
    The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, with claiming, this product contains Low Dermatitis Potential Claim and tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile compound, Blue color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.
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    K Number
    K181066
    Device Name
    Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims
    Manufacturer
    ECO Medi Glove Sdn Bhd
    Date Cleared
    2018-09-26

    (156 days)

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

    ECO Medi Glove Sdn Bhd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nitrile Powder Free Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner. In addition these gloves was tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by Chemotherapy Drugs.
    Device Description
    The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, with Low Dermatitis Potential Claim and tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile compound, Blue color, powder free and nonsterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, and ASTM D6978-05 and Modified Draize 95 test.
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    K Number
    K161187
    Device Name
    EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs
    Manufacturer
    ECO MEDI GLOVE SDN BHD
    Date Cleared
    2016-09-09

    (135 days)

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

    ECO MEDI GLOVE SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free patient eaxmination 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 for use with chemotherapy drugs.In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.
    Device Description
    The subject device in this 510(k) Notification is EMG Blue Nitrile Examination Gloves Powder Free with tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile latex compound, Blue colour, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs. The Blue Nitrile Medical Examination Gloves ,Powder Free, 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 (product Code LZA) and is used with chemotherapy drugs (Product code LZC). The subject device is substantially equivalent to the legally marketed Nitrile Medical Examination Gloves (product Code LZA and LZC).
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    K Number
    K141623
    Device Name
    EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIM
    Manufacturer
    ECO MEDI GLOVE SDN BHD
    Date Cleared
    2014-10-07

    (112 days)

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

    ECO MEDI GLOVE SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Powder Free Examination Glove is a disposable device intended for Medical Purpose that is worn on the examiner's hand of fingers to prevent contamination between patient and examiner and for use with Chemotherapy Drugs In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by Chemotherapy drugs
    Device Description
    The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, powder free, with tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile latex compound, Blue colour, powder free and non sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs.
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