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510(k) Data Aggregation

    K Number
    K991640
    Device Name
    HEALTH AID PREMIUM PRE-POWDERED NITRILE EXAMINATION GLOVES
    Manufacturer
    M.R.G. INDUSTRIES BERHAD
    Date Cleared
    1999-05-28

    (16 days)

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

    M.R.G. INDUSTRIES BERHAD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HEALTH + AID ° PREMIUM 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
    HEALTH + AID ® PREMIUM Pre - Powdered Nitrile Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 -- 95, Standard Specificatio for Rubber Examination Gloves. They are blu or natural white in colour.
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