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510(k) Data Aggregation
K Number
K142703Device Name
Powder-free PVC Vinyl Exam Gloves
Manufacturer
Date Cleared
2015-01-15
(115 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Hebei Grandeast Plastic Products Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Powder-free PVC Vinyl Exam Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Device Description
The proposed devices, Powder-free PVC Vinyl Exam Gloves are non-sterile, non-colored and disposable medical gloves intended to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
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