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510(k) Data Aggregation
K Number
K072639Device Name
YUYUAN LATEX EXAMINATION GLOVE, POWDERED
Manufacturer
Date Cleared
2007-11-19
(62 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANDONG YUYUAN LATEX GLOVES COMPANY LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Yuyuan, Latex Examination Glove is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." (21CFR 880.6250)
Device Description
Natural rubber latex films form a barrier to body fluids and bloodborne pathogens. The latex rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Natural rubber latex is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the reguirements of ASTM D3578-06 and ASTM D5151 requirements.
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