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510(k) Data Aggregation
K Number
K153159Device Name
Vinyl patient examination glove, Powder Free
Manufacturer
Date Cleared
2016-01-26
(85 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
XINGYUAN PLASTIC PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Vinyl patient examination glove, Powder Free, is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Device Description
The proposed device, Vinyl patient examination glove, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The proposed is Powder Free Vinyl Patient Examination Gloves without color, and includes variations of different size.
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