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Aero Blue Performance Surgical Gowns

by O&M Halyard, Inc.

510(k) K192362

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK192362 Date13 Dec 2019ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0343-2023 FDA Class II initiated 31 Oct 2022

    Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FYA
Device Class
Class II
Regulation
21 CFR Part 878.4040
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Aero Blue Performance Surgical Gowns are protective garments designed to provide a barrier against fluids and pathogens during surgical procedures. These gowns feature a breathable back panel and are engineered to meet AAMI Level 3 and Level 4 liquid barrier standards, as well as ASTM F1670 standards for material resistance.

The gowns are available in various sizes, including Large/X-Long and XXL, and may be supplied with a towel. This device has received FDA 510k clearance. Users should consult the specific product packaging for information regarding sterility, intended use settings, and storage requirements.

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