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510(k) Data Aggregation
K Number
K153732Device Name
Powder Free Blue Nitrile Examination Glove
Manufacturer
Date Cleared
2016-07-29
(214 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
QUBE MEDICAL PRODUCT SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
Powder Free Blue Nitrile Examination Glove
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K Number
K123537Device Name
POWDER FREE LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
2014-02-12
(453 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
QUBE MEDICAL PRODUCT SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand or finger to prevent contamination between patient and examiner.
Device Description
Powder Free Latex Examination Glove
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