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510(k) Data Aggregation
K Number
K173228Device Name
U-MED Powder Free Polyethylene Examination Gloves,Blue Color
Manufacturer
Date Cleared
2018-02-20
(139 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
**Jiangsu U-MED Rubber **& Plastic Products Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder Free Polyethylene Examination Gloves,Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
The U-MED Powder Free Polyethylene Examination Gloves,Blue Color are nonsterile disposable Patient examination glove. The gloves are made of translucent (clear), Low Density Polyethylene material and are powder free. The U-MED Powder Free Polyethylene Examination Gloves,Blue Color come in four sizes: Small, Medium, Large, X Large. The Powder Free Polyethylene Examination Gloves, Blue Color acts as a barrier to prevent contamination between patient and examiner. The physical and performance characteristics of the devices meets all requirements of ASTM D5250 and ASTM D5151.
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