Submission Details
| 510(k) Number | K193327 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 02, 2019 |
| Decision Date | March 20, 2020 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve
Mar 2020
Decision
109d
Days
Class 2
Risk
About This 510(k) Submission
K193327 is an FDA 510(k) clearance for the Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve, a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on March 20, 2020, 109 days after receiving the submission on December 2, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.
Device Classification
| Product Code | FYA — Gown, Surgical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4040 |
Manufacturer
Similar Devices — FYA Gown, Surgical
All 290
K251860 · Copioumed International, Inc.
· Feb 2026
K252301 · Yadu Medical (Henan) Co., Ltd.
· Feb 2026
K250564 · Yadu Medical (Henan) Co., Ltd.
· Dec 2025
K243522 · Thi Total Healthcare Innovation GmbH
· May 2025
K242937 · Dae Myung Chemical Co., Ltd. (Vietnam)
· May 2025
K242844 · Medline Industries, LP
· Feb 2025
More from Cardinal Health200, LLC
View all
K241780
· LZA · Aug 2024
K230838
· FYA · Jul 2023
K223376
· MEG · Jun 2023
K230028
· JOW · Apr 2023
K201592
· KGO · Sep 2021