FDA 510(k)

Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets

K-Number: K230838 · 2023-07-27

Decision Date2023-07-27

Product CodeFYA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets is a medical device manufactured by Cardinal Health200, LLC. It received FDA 510(k) clearance on 2023-07-27 under approval number K230838. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets?

Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets is a medical device that received FDA 510(k) clearance on 2023-07-27. It is manufactured by Cardinal Health200, LLC. The 510(k) number is K230838.

When was Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets approved by the FDA?

Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets received FDA 510(k) clearance on 2023-07-27, under approval number K230838.

What company makes Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets?

Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets is manufactured by Cardinal Health200, LLC.

What is the FDA product code for Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets?

The FDA product code for Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets is FYA.

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Related PubMed Literature

PMID: 41572440 Regulating Medical Devices: The Values and Politics of the US FDA Review Process. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

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Related Devices (Code: FYA)

K162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500Gri Medical & Electrical Technology Co., Ltd. K150598Blockade Surgical GownMedline Industries, Inc. K153255Aero Chrome* Breathable Performance Surgical GownHalyard Health, Inc. K172445RoyalGuard Surgical Gown, i600, BreathableGri Medical & Electrical Technology Co., Ltd. K170762Cardinal Health Non-Reinforced Surgical GownCardinal Health200, LLC K162930Aero Chrome* Select Breathable Performance Surgical GownsHalyard Health, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.