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510(k) Data Aggregation
K Number
K142892Device Name
Powder-free Clear Vinyl Patient Examination Gloves
Manufacturer
Date Cleared
2015-03-25
(173 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Shenyi(Shandong) 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 fingers to prevent contamination between patient and examiner.
Device Description
The subject device is Powder-Free Vinyl Patient Examination Gloves that is worn upon the examiner's hands or finger. As a barrier, the subject device prevents contamination between patient and examiner. The subject device meets all of the requirements of ASTM standards D5250-06 for Physical and performance characteristics, D5151-06 for barrier properties and D6124-06 for residual powder.
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