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510(k) Data Aggregation
K Number
K140322Device Name
WHITE VINYL EXAM GLOVES POWDER FREE
Manufacturer
SHANDONG DAWEI MEDICAL PRODUCTS CO., LTD.
Date Cleared
2014-06-12
(122 days)
Product Code
LYZ
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
SHANDONG DAWEI 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 lingers to prevent contamination between patient and examiner.
Device Description
White Vinyl Exam Gloves Powder Free 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. Classified by FDA's General and Plastic Surgery Device panel as Class I. 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove. 80LYZ. and meets all requirement of ASTM Standard D5250-06.
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