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FDA 510(k)

AERO CHROME* Breathable Performance Surgical Gowns

K-Number: K200522 · 2020-03-16

ApplicantO&M Halyard, Inc.
Decision Date2020-03-16
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AERO CHROME* Breathable Performance Surgical Gowns is a medical device manufactured by O&M Halyard, Inc.. It received FDA 510(k) clearance on 2020-03-16 under approval number K200522. 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 Gowns?

AERO CHROME* Breathable Performance Surgical Gowns is a medical device that received FDA 510(k) clearance on 2020-03-16. It is manufactured by O&M Halyard, Inc.. The 510(k) number is K200522.

When was AERO CHROME* Breathable Performance Surgical Gowns approved by the FDA?

AERO CHROME* Breathable Performance Surgical Gowns received FDA 510(k) clearance on 2020-03-16, under approval number K200522.

What company makes AERO CHROME* Breathable Performance Surgical Gowns?

AERO CHROME* Breathable Performance Surgical Gowns is manufactured by O&M Halyard, Inc..

What is the FDA product code for AERO CHROME* Breathable Performance Surgical Gowns?

The FDA product code for AERO CHROME* Breathable Performance Surgical Gowns is FYA.

Related Clinical Trials

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Other Devices by O&M Halyard, Inc.

K192362Aero Blue Performance Surgical Gowns K191230Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves K182851SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs K183132Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs K200843Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs K211063HALYARD Flexaprene Green Powder-Free Exam Glove

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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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