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510(k) K160411

Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating by Cardinal Health, Inc. — Product Code LYZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2016
Date Received
February 16, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vinyl Patient Examination Glove
Device Class
Class I
Regulation Number
880.6250
Review Panel
HO
Submission Type

A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

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