K-number	K160411
Device name	Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating
Applicant	Cardinal Health, Inc.
Product code	LYZ
Device class	Class I
Decision date	Jul 25, 2016
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating

Everything you need for a 510(k) submission. Nothing you don't.