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510(k) Data Aggregation
K Number
K113194Device Name
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR
Manufacturer
Date Cleared
2012-05-14
(196 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUQIAN RUIJANG MEDICAL SUPPLIES CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder Free Vinyl Patient Examination Gloves,White Color is a non-sterile 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
Powder Free Vinyl Patient Examination Gloves,White Color are disposable devices which made of PVC material ,intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.
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K Number
K113193Device Name
PATIENT EXAMINATION GLOVE
Manufacturer
Date Cleared
2011-12-16
(46 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUQIAN RUIJANG MEDICAL SUPPLIES CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile 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
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) are disposable devices which made of PVC material ,intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.
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K Number
K113191Device Name
POWER FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
Manufacturer
Date Cleared
2011-11-17
(17 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUQIAN RUIJANG MEDICAL SUPPLIES CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder Free Vinyl Patient Examination Gloves, Yellow Color is a non-sterile 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
Powder Free Vinyl Patient Examination Gloves, Yellow Color are disposable devices which made of PVC material ,intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.
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K Number
K113195Device Name
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Manufacturer
Date Cleared
2011-11-16
(16 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SUQIAN RUIJANG MEDICAL SUPPLIES CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powdered Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile 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
Powdered Vinyl Patient Examination Gloves, Clear (non-colored) are disposable devices which made of PVC material, intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.
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Ask a specific question about this device
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