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510(k) Data Aggregation
K Number
K122656Device Name
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
Manufacturer
Date Cleared
2014-05-06
(613 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANDONG YIFAN PLASTIC 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 finger to prevent contamination between patient and examiner.
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, and meets all requirement of ASTM Standard D5250-06. The subject device is a garment covering the hand and wrist area. Clovers have separate sheaths or openings for each finger and the thumb. And vinyl films form a barrier to body fluid and blood-borne pathogens, and that the vinyl rubber is water tight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
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