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510(k) Data Aggregation
K Number
K083931Device Name
SYNTHETIC POWDER-FREE EXAM VINYL GLOVES, YELLOW/WHITE
Manufacturer
Date Cleared
2009-04-27
(143 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
QUANTUM CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K083600Device Name
VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED)
Manufacturer
Date Cleared
2009-02-19
(76 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
QUANTUM CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder-free vinyl Examination glove, clear (non-colored) 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
The Powder-free vinyl Examination glove, clear (Non-colored) is disposable device made PVC resin and plasticizers (DINP), Ca-Zn stabilizer, TXIB into film, coated with Polyurethane to facilitate donning and it intended to be worn on the hand of finger(s) for medical purpose to provide a barrier against potentially infectious materials and other contaminants.
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