Name: Predicase
Price: 199 USD

K-number	K230838
Device name	Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets
Applicant	Cardinal Health200, LLC
Product code	FYA
Device class	Class II
Decision date	Jul 27, 2023
Decision	Substantially Equivalent
Regulation	878.4040

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets

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

Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets