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510(k) Data Aggregation

    K Number
    K011791
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR
    Manufacturer
    LATEXX PARTNERS BHD.
    Date Cleared
    2001-08-01

    (54 days)

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

    LATEXX PARTNERS BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powder Free Nitrile Examination Glove, Violet Color is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
    Device Description
    Powder Free Nitrile Examination Gloves, Violet Color meet the current ASTM Standard Specification for Nitrile Examination Gloves for Medical Application. It also meets all the current specifications listed under the ASTM Specification D 6913-00a Standard Specification for Nitrile Examination Gloves. They are violet in colour and are powder free.
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    K Number
    K011792
    Device Name
    NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
    Manufacturer
    LATEXX PARTNERS BHD.
    Date Cleared
    2001-08-01

    (54 days)

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

    LATEXX PARTNERS BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powder Free Nitrile Examination Glove, Blue Color is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
    Device Description
    Non-chlorinated, Polymer Coated, Powder Free Nitrile Examination Gloves, Blue Color meet the current ASTM Standard Specification for Nitrile Examination Gloves for Medical Application. It also meets all the current specifications listed under the ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves. They are blue in colour and are powder free.
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    K Number
    K992924
    Device Name
    QTEXX, NON-CHLORINATED, POWDER FREE NITRILE EXAMINATION GLOVES, POLYMER-COATED
    Manufacturer
    LATEXX PARTNERS BHD.
    Date Cleared
    1999-11-05

    (67 days)

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

    LATEXX PARTNERS BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QTEXX, Non - Chlorinated Powder free Nitrile Examination Glove, polymer-coated is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
    Device Description
    QTEXX, Non - Chlorinated, Powder Free Nitrile Examination Gloves, Polymer-coated meet the current specification listed under the ASTM Specification D 3578 – 99, Standard Specification for Rubber Examination Gloves, They are blue or natural white in colour and are powder free.
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    K Number
    K992671
    Device Name
    QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES
    Manufacturer
    LATEXX PARTNERS BHD.
    Date Cleared
    1999-09-24

    (45 days)

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

    LATEXX PARTNERS BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QTEXX Pre - Powdered Nitrile Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
    Device Description
    QTEXX Pre - Powdered Nitrile Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 - 99 Standard Specification for Rubber Examination Gloves. They are blue or natural white in colour.
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    K Number
    K991462
    Device Name
    QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED
    Manufacturer
    LATEXX PARTNERS BHD.
    Date Cleared
    1999-05-28

    (31 days)

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

    LATEXX PARTNERS BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QTEXX Powder free Latex Examination Glove, polymer-coated is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
    Device Description
    QTEXX Powder Free Latex Examination Gloves, Polymer-coated meet the current specification listed under the ASTM Specification D 3578 - 95, Standard Specification for Rubber Examination Gloves, They are natural white in colour and are powder free.
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    K Number
    K981767
    Device Name
    QTEXX POWDERFREE LATEX EXAMINATION GLOVES
    Manufacturer
    LATEXX PARTNERS BHD.
    Date Cleared
    1998-06-11

    (23 days)

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

    LATEXX PARTNERS BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QTEXX Powderfree Latex Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
    Device Description
    QTEXX Powder Free Latex Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 - 95, Standard Specification for Rubber Examination Gloves. They are natural white in colour and are powder free.
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    K Number
    K981159
    Device Name
    PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES
    Manufacturer
    LATEXX PARTNERS BHD.
    Date Cleared
    1998-06-01

    (62 days)

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

    LATEXX PARTNERS BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Proflex Powderfree Nitrile Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
    Device Description
    PROFLEX* Powder Free Nitrile Examination Gloves meet the current draft ASTM Standard Specification for Nitrile Examination Gloves for Medical Application. It also meets all the current specifications listed under the ASTM Specification D 3578 – 95, Standard Specification for Rubber Examination Gloves, EXCEPT for tensile strength and ultimate elongation requirement. They are blue or natural white in colour and are powder free.
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