Submission Details
| 510(k) Number | K030364 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 04, 2003 |
| Decision Date | April 28, 2003 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
Cleared
Traditional
DEROYAL GOWNS, STERILE, NON-STERILE
Apr 2003
Decision
83d
Days
Class 2
Risk
About This 510(k) Submission
K030364 is an FDA 510(k) clearance for the DEROYAL GOWNS, STERILE, NON-STERILE, a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by Deroyal Industries, Inc. (Knoxville, US). The FDA issued a Cleared decision on April 28, 2003, 83 days after receiving the submission on February 4, 2003. 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 Deroyal Industries, Inc.
View all
K250586
· OMP · Nov 2025
K230233
· OMP · Apr 2024
K200631
· FLL · Dec 2020
K200757
· EYC · Oct 2020
K193027
· BZT · Apr 2020