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Found 9 results
510(k) Data Aggregation
K Number
K133193Device 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
880.6250Why 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
K112924Device 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
880.6250Why 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
K112928Device 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
880.6250Why 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
K100603Device 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
880.6250Why 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
K100611Device 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
880.6250Why 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
K003233Device 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
880.6250Why did this record match?
Applicant Name (Manufacturer) :
RIVERSTONE RESOURCES SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003232Device 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
880.6250Why did this record match?
Applicant Name (Manufacturer) :
RIVERSTONE RESOURCES SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K992558Device 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
880.6250Why 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
K990963Device 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
880.6250Why 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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