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FDA 510(k)

Aero Chrome* Breathable Performance Surgical Gown

K-Number: K153255 · 2016-04-13

ApplicantHalyard Health, Inc.
Decision Date2016-04-13
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Aero Chrome* Breathable Performance Surgical Gown is a medical device manufactured by Halyard Health, Inc.. It received FDA 510(k) clearance on 2016-04-13 under approval number K153255. 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 Aero Chrome* Breathable Performance Surgical Gown?

Aero Chrome* Breathable Performance Surgical Gown is a medical device that received FDA 510(k) clearance on 2016-04-13. It is manufactured by Halyard Health, Inc.. The 510(k) number is K153255.

When was Aero Chrome* Breathable Performance Surgical Gown approved by the FDA?

Aero Chrome* Breathable Performance Surgical Gown received FDA 510(k) clearance on 2016-04-13, under approval number K153255.

What company makes Aero Chrome* Breathable Performance Surgical Gown?

Aero Chrome* Breathable Performance Surgical Gown is manufactured by Halyard Health, Inc..

What is the FDA product code for Aero Chrome* Breathable Performance Surgical Gown?

The FDA product code for Aero Chrome* Breathable Performance Surgical Gown is FYA.

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Other Devices by Halyard Health, Inc.

K163236COOLIEF Cooled Radiofrequency Kit K162930Aero Chrome* Select Breathable Performance Surgical Gowns K163461Coolief* Cooled RF Probe K173955Mic-Key* SF Over-the-Wire Stoma Measuring Device

Related Devices (Code: FYA)

K162442ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500Gri Medical & Electrical Technology Co., Ltd. K150598Blockade Surgical GownMedline Industries, 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. 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.

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