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FDA 510(k)

Aero Blue Performance Surgical Gowns

K-Number: K192362 · 2019-12-13

ApplicantO&M Halyard, Inc.
Decision Date2019-12-13
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Aero Blue Performance Surgical Gowns is a medical device manufactured by O&M Halyard, Inc.. It received FDA 510(k) clearance on 2019-12-13 under approval number K192362. 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 Blue Performance Surgical Gowns?

Aero Blue Performance Surgical Gowns is a medical device that received FDA 510(k) clearance on 2019-12-13. It is manufactured by O&M Halyard, Inc.. The 510(k) number is K192362.

When was Aero Blue Performance Surgical Gowns approved by the FDA?

Aero Blue Performance Surgical Gowns received FDA 510(k) clearance on 2019-12-13, under approval number K192362.

What company makes Aero Blue Performance Surgical Gowns?

Aero Blue Performance Surgical Gowns is manufactured by O&M Halyard, Inc..

What is the FDA product code for Aero Blue Performance Surgical Gowns?

The FDA product code for Aero Blue Performance Surgical Gowns is FYA.

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Other Devices by O&M Halyard, Inc.

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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.

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