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510(k) Data Aggregation
K Number
K153028Device Name
Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue
Manufacturer
ZIBO HUIYING MEDICAL PRODUCTS, CO. LTD.
Date Cleared
2016-02-05
(112 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ZIBO HUIYING MEDICAL PRODUCTS, CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Gloves, LYZ, and meets all requirements of ASTM D5250-06.
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