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510(k) Data Aggregation
K Number
K111459Device Name
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
Manufacturer
Date Cleared
2011-06-16
(21 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
JIANGSU ALFA GLOVE CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powdered Free Vinyl Patient Examination Gloves, Light 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
Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.
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K Number
K081658Device Name
POWDER-FREE VINYL EXAMINATION GLOVES
Manufacturer
Date Cleared
2008-09-30
(110 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
JIANGSU ALFA GLOVE CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder free vinyl 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
powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
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