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510(k) Data Aggregation
K Number
K052729Device Name
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
Manufacturer
Date Cleared
2006-01-19
(112 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHIJIAZHUANG BRILLIANT OCEAN PLASTIC CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powdered vinyl patient examination glove 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
powdered vinyl patient examination gloves, white(non-colored) that mects all of the requirements of ASTM standard D 5250-0004.
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