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510(k) Data Aggregation
K Number
K211865Device Name
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Manufacturer
Date Cleared
2021-12-20
(187 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Liao Ning Shangwei Medical Products Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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
The subject device is disposable medical PVC gloves that made from PVC compound, Clear (non-colored), powder free and nonsterile. The device meets the specifications in ASTM D5250-06(Reapproved 2015) Standard specification for poly (vinyl chloride) gloves for medical application.
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