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510(k) Data Aggregation

    K Number
    K133193
    Device Name
    RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
    Manufacturer
    RIVERSTONE RESOURCES SDN. BHD.
    Date Cleared
    2014-06-23

    (249 days)

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

    RIVERSTONE RESOURCES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Orange Nitrile Medical Examination gloves powder free, non sterile, as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. They are made nitrile from nitrile latex compound, orange colour, powder free and non sterile.
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    K Number
    K112924
    Device Name
    RS SAFE BLACK NITRILE MEDICAL EXAMINATION GLOVES POWDER OR OTHER PROPRIETARY NAME
    Manufacturer
    RIVERSTONE RESOURCES SDN. BHD.
    Date Cleared
    2012-05-02

    (212 days)

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

    RIVERSTONE RESOURCES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device is for over-the-counter use.
    Device Description
    RS BLACK Black Medical Examination Nitrile gloves (powder free) as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard Specification for Nitrile Examination Gloves. They are made from nitrile latex compound, black colour and powder free.
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    K Number
    K112928
    Device Name
    RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER PROPRIETARY NAME
    Manufacturer
    RIVERSTONE RESOURCES SDN. BHD.
    Date Cleared
    2012-04-17

    (197 days)

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

    RIVERSTONE RESOURCES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is for over-the-counter use.
    Device Description
    White Nitrile Medical Examination gloves powder free, non sterile, as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard Specification for Nitrile Examination Gloves. They are made from nitrile latex compound, white colour, powder free and non sterile.
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    K Number
    K100603
    Device Name
    RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
    Manufacturer
    RIVERSTONE RESOURCES SDN. BHD.
    Date Cleared
    2010-07-16

    (135 days)

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

    RIVERSTONE RESOURCES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Nitrile Examination gloves powder free blue colour as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-00a, Standard Specification for Nitrile Examination Gloves. They are made from nitrile latex compound, blue colour and powder free.
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    K Number
    K100611
    Device Name
    RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE)
    Manufacturer
    RIVERSTONE RESOURCES SDN. BHD.
    Date Cleared
    2010-07-16

    (135 days)

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

    RIVERSTONE RESOURCES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Latex Examination gloves powder free as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LYY (21CFR 880.6250). It meets all the specifications in ASTM D 3578-05, Standard Specification for Latex Examination Gloves. They are made from natural latex compound and powder free.
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    K Number
    K003233
    Device Name
    RS NITRILSTST MEDICAL EXAMINATION GLOVES, POWDERED (NON STERILE) BLUE
    Manufacturer
    RIVERSTONE RESOURCES SDN. BHD.
    Date Cleared
    2000-11-03

    (17 days)

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

    RIVERSTONE RESOURCES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K003232
    Device Name
    RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)
    Manufacturer
    RIVERSTONE RESOURCES SDN. BHD.
    Date Cleared
    2000-10-26

    (9 days)

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

    RIVERSTONE RESOURCES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K992558
    Device Name
    NITRILE PATIENT EXAMINATION GLOVES, POWDERED, NON-STERILE
    Manufacturer
    RIVERSTONE RESOURCES SDN. BHD.
    Date Cleared
    1999-09-27

    (59 days)

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

    RIVERSTONE RESOURCES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A medical gloves is worn on hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    Nitrile Patient Examination Gloves, Trade Name: Powdered, Non-Sterile
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    K Number
    K990963
    Device Name
    RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)
    Manufacturer
    RIVERSTONE RESOURCES SDN. BHD.
    Date Cleared
    1999-05-26

    (64 days)

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

    RIVERSTONE RESOURCES SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A medical gloves is worn on hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    RS Nitrilstat Medical Examination Gloves, Powder Free (Non-Sterile)
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