FDA 510(k)

Cardinal Health Non-Reinforced Surgical Gown

K-Number: K170762 · 2017-06-09

Decision Date2017-06-09

Product CodeFYA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Cardinal Health Non-Reinforced Surgical Gown is a medical device manufactured by Cardinal Health200, LLC. It received FDA 510(k) clearance on 2017-06-09 under approval number K170762. 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 Non-Reinforced Surgical Gown?

Cardinal Health Non-Reinforced Surgical Gown is a medical device that received FDA 510(k) clearance on 2017-06-09. It is manufactured by Cardinal Health200, LLC. The 510(k) number is K170762.

When was Cardinal Health Non-Reinforced Surgical Gown approved by the FDA?

Cardinal Health Non-Reinforced Surgical Gown received FDA 510(k) clearance on 2017-06-09, under approval number K170762.

What company makes Cardinal Health Non-Reinforced Surgical Gown?

Cardinal Health Non-Reinforced Surgical Gown is manufactured by Cardinal Health200, LLC.

What is the FDA product code for Cardinal Health Non-Reinforced Surgical Gown?

The FDA product code for Cardinal Health Non-Reinforced Surgical Gown 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) PMID: 36393892 Developing minimum core data structure for the obesity devices Coordinated Registry Network (CRN). BMJ surgery, interventions, & health technologies (2022) PMID: 30461340 The Importance of Design Validation in Global Health Surgical Innovation. Surgical innovation (2018)

Other Devices by Cardinal Health200, LLC

K160339Cardinal Health Isolation Gown K161910Cardinal Health Sterilization Wrap K181174Cardinal Health Sterilization Wrap K192374Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip K182830Cardinal HealthTM Poly-Coated Open-Back Protective Gown K200824Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown

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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. K162930Aero Chrome* Select Breathable Performance Surgical GownsHalyard Health, Inc. K163191ComfortGuard Surgical Gown, i600, Film ReinforcedGri Medical & Electrical Technology Co., Ltd.

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.