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FDA 510(k)

Aero Chrome* Select Breathable Performance Surgical Gowns

K-Number: K162930 · 2017-04-21

ApplicantHalyard Health, Inc.
Decision Date2017-04-21
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Aero Chrome* Select Breathable Performance Surgical Gowns is a medical device manufactured by Halyard Health, Inc.. It received FDA 510(k) clearance on 2017-04-21 under approval number K162930. 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* Select Breathable Performance Surgical Gowns?

Aero Chrome* Select Breathable Performance Surgical Gowns is a medical device that received FDA 510(k) clearance on 2017-04-21. It is manufactured by Halyard Health, Inc.. The 510(k) number is K162930.

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

Aero Chrome* Select Breathable Performance Surgical Gowns received FDA 510(k) clearance on 2017-04-21, under approval number K162930.

What company makes Aero Chrome* Select Breathable Performance Surgical Gowns?

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

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

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

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07607860 Clinical Evaluation of the Adaptilens Accommodating IOL NOT_YET_RECRUITING NCT07607457 Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery NOT_YET_RECRUITING NCT07470411 Safety and Feasibility of the MACS in Surgical Procedures: A Prospective Multi-Center Study RECRUITING NCT04761120 Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study RECRUITING NCT07185191 Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS) RECRUITING

Related PubMed Literature

PMID: 41460256 Benchmarking THA Implant Combinations Using Data From a US Total Joint Replacement Registry. Clinical orthopaedics and related research (2026)

Other Devices by Halyard Health, Inc.

K163236COOLIEF Cooled Radiofrequency Kit K153255Aero Chrome* Breathable Performance Surgical Gown 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. 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 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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