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510(k) Data Aggregation
K Number
K123328Device Name
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK
Manufacturer
Date Cleared
2013-01-18
(88 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
NITRILIST GLOVES MANUFACTURING SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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.
Device Description
POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK
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K Number
K122874Device Name
POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE
Manufacturer
Date Cleared
2012-12-10
(82 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
NITRILIST GLOVES MANUFACTURING SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A powdered 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
Powdered Nitrile Examination Gloves, Blue
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