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510(k) Data Aggregation
K Number
K162113Device Name
Powder Free Nitrile Examination Gloves (Blue)
Manufacturer
Date Cleared
2016-11-07
(101 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
NAM VIET GLOVE 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 hands or fingers to prevent contamination between patient and examiner.
Device Description
The Powder Free Nitrile Examination Gloves (Blue) meets all the requirements of ASTM Specification D6319-10 - Standard Specification for Nitrile Examination Gloves for Medical Application.
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