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510(k) Data Aggregation
K Number
K170735Device Name
Powder-Free Clear Vinyl Patient Examination Gloves
Manufacturer
Date Cleared
2017-06-27
(109 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Zibo Yue Fan Medical Products Co, Ltd.
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 upon the examiner's hands or fingers to prevent contamination between patient and examiner.
Device Description
Subject device: Powder Free Clear Vinyl Patient Examination Glove Color: Clear Overall Length: 230mm min Width: 94mm min Palm Thickness: 0.09 mm min Fingertip Thickness: 0.086 mm min
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