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510(k) Data Aggregation
K Number
K151208Device Name
Powder Free Nitrile Examination Glove
Manufacturer
Date Cleared
2015-09-14
(131 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
VRG KHAI HOAN JOINT STOCK COMPANY
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 NITRILE EXAMINATION GLOVE
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K Number
K113685Device Name
POWDER FREE LATEX EXAMINATION GLOVES
Manufacturer
Date Cleared
2012-08-10
(239 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
KHAI HOAN JOINT STOCK COMPANY
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 LATEX EXMAINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 µg/dm² OR LESS
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K Number
K092681Device Name
POWDERED LATEX EXAMINATION GLOVES, NON-STERILE
Manufacturer
Date Cleared
2010-02-23
(175 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
KHAI HOAN JOINT STOCK COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Natural Rubber Late: a non-colored, single use amination ce inte on the hand of med nded to If to prevent contamination between the patie neand examine
Device Description
POWDERED LATEX EXAMINATION GLOVES (NON-COLORED)
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