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510(k) Data Aggregation

    K Number
    K991153
    Device Name
    MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTA\
    Manufacturer
    MEDTEXX INDUSTRIES (THAI) CO. LTD.
    Date Cleared
    1999-06-21

    (76 days)

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

    MEDTEXX INDUSTRIES (THAI) CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Medtexx Powder free 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
    MEDTEXX 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 color and are powder free.
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