Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K120963
    Device Name
    POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
    Date Cleared
    2012-06-29

    (91 days)

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

    MEDTEXX MANUFACTURING SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

    Ask a specific question about this device

    K Number
    K071740
    Device Name
    CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVES
    Date Cleared
    2007-10-04

    (99 days)

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

    MEDTEXX MANUFACTURING SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Blue Colour, Chlorinated Powder Free Nitrile Examination Glove 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
    The Blue Colour, Chlorinated Powder Free Nitrile Examination Gloves is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LZA ( 21 CFR 880.6250 ). It meets all the current specifications listed under the ASTM Specification D 6319 - 00a Standard Specification for Nitrile Examination Gloves for Medical Application1. They are made from nitrile compound(dispersion of butadiene acrylonitrile copolymer. They are blue in color and are powder free.
    Ask a Question

    Ask a specific question about this device

    K Number
    K070821
    Device Name
    POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE
    Date Cleared
    2007-05-10

    (45 days)

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

    MEDTEXX MANUFACTURING SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Powdered Natural Rubber Latex Examination Glove 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
    Powdered Natural Rubber Latex Examination Glove is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LYY ( 21 CFR 880.6250 ). It meets all the current specifications listed under the ASTM Specification D-3578-05, Standard Specification for Rubber Examination Gloves. They are made from natural rubber latex. They are natural white in color and are powdered.
    Ask a Question

    Ask a specific question about this device

    K Number
    K070072
    Device Name
    NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES
    Date Cleared
    2007-03-15

    (66 days)

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

    MEDTEXX MANUFACTURING SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.
    Device Description
    Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Glove is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LYY ( 21 CFR 880.6250 ). It meets all the current specifications listed under the ASTM Specification D-3578-05, Standard Specification for Rubber Examination Gloves. They are made from natural rubber latex. They are natural white in color and are powder free.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1