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510(k) Data Aggregation

    K Number
    K991304
    Device Name
    HEALTH + AID PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
    Date Cleared
    1999-06-23

    (68 days)

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

    M.R.G. INDUSTRIES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HEALTH + AID PREMIUM Powderfree Nitrike 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 Powder Free Nitrile Examination Gloves meet all the current specification listed under the ASTM Specification Examination Gloves, EXCEPT for ultimate elongation before ageing. They are blue or natural white in colour and are powder free.
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    K Number
    K991305
    Device Name
    HEALTH + AID PREMIUM POWDER FREE LATEX EXAMINATION GLOVES
    Date Cleared
    1999-06-21

    (66 days)

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

    M.R.G. INDUSTRIES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HEALTH + AID @ PREMIUM 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 contanination between the health care personnel and the patient.
    Device Description
    HEALTH + AID ® PREMIUM 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
    K981893
    Device Name
    HEALTH + AID PREMIUM PRE-POWDERED LATEX EXAMINATION GLOVES
    Date Cleared
    1998-06-22

    (24 days)

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

    M.R.G. INDUSTRIES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HEALTH + AID® PREMIUM Pre-powdered 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. 100mcg/gm or less total water extractable protein per gram
    Device Description
    HEALTH + AID® PREMIUM Pre-powdered Latex Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 - 95, Standard Specification for Rubber Examination Gloves. They are
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