Name: Predicase
Price: 199 USD

K-number	K160875
Device name	Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating
Applicant	Cardinal Health, Inc.
Product code	KGO
Device class	Class I
Decision date	Jul 11, 2016
Decision	Substantially Equivalent
Regulation	878.4460

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Source

View the full FDA submission: accessdata.fda.gov

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Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating

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