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510(k) Data Aggregation
K Number
K102570Device Name
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
Manufacturer
Date Cleared
2010-10-21
(44 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
TANGSHAN KANGJIE GLOVE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) is a 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
Powder free Vinyl Patient Examination Gloves, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.
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