FDA product code FYA: Gown, Surgical
FYA is the FDA product code for gown, surgical. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel. FDA has cleared 298 510(k) submissions under FYA, 54 in the last five years, from 177 different applicants. The average 510(k) review took 165 days (median 130); 189 days on average over the last three years. FDA has posted 129 recalls for FYA devices, 19 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Gown, Surgical |
| Device class | Class II |
| Regulation | 21 CFR 878.4040 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for FYA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 123 |
| 2018 | 2 | 276 |
| 2019 | 5 | 180 |
| 2020 | 7 | 138 |
| 2021 | 17 | 176 |
| 2022 | 24 | 264 |
| 2023 | 12 | 215 |
| 2024 | 5 | 175 |
| 2025 | 4 | 214 |
| 2026 | 9 | 177 |
Compare with all 510(k) review times · Search every FYA clearance
Top FYA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Standard Textile Co., Inc. | 14 | 2024-09-10 |
| Medline Industries, Inc. | 13 | 2021-04-02 |
| Kimberly-Clark Corp. | 11 | 2010-12-23 |
| Allegiance Healthcare Corp. | 8 | 2002-10-02 |
| The Sewing Source, Inc. | 8 | 1993-07-09 |
172 more applicants have FYA clearances. See the full list in Caduvo.
Most recent FYA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260407 | Principle & Will Co., Ltd. | Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns | 2026-08-26 | 198 |
| K261028 | Yadu Medical (Henan) Co., Ltd. | Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) | 2026-08-07 | 130 |
| K261949 | New York Embroidery Studio | NYES Tuff Cuff L3 Disposable Gowns | 2026-07-10 | 29 |
| K252575 | New York Embroidery Studio (NYES) | Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) | 2026-06-04 | 294 |
| K260725 | Hindernis DE Mexico, S.A.P.I. DE C.V. | BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) | 2026-05-12 | 68 |
Recalls for FYA devices
129 product recalls in 27 recall events; 19 initiated in the last five years and 21 still open. Most recent: 2026-01-28.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 12 |
| 2020 | 40 |
| 2021 | 11 |
| 2022 | 2 |
| 2023 | 1 |
| 2025 | 1 |
| 2026 | 4 |
Frequently asked questions
What is FDA product code FYA?
FYA is the FDA product code for gown, surgical. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel.
What device class is FYA?
Class II, regulation 21 CFR 878.4040. Typical premarket route: 510(k).
How long does a 510(k) take for product code FYA?
Across 298 cleared submissions the average was 165 days from receipt to decision (median 130).
Which companies have the most FYA clearances?
Standard Textile Co., Inc. (14); Medline Industries, Inc. (13); Kimberly-Clark Corp. (11); Allegiance Healthcare Corp. (8); The Sewing Source, Inc. (8).
Have FYA devices been recalled?
Yes: 129 product recalls across 27 recall events; the most recent began 2026-01-28.
Next steps
- Run an FDA pathway report with predicate devices for product code FYA
- Run a recall and safety report across every FYA manufacturer
- Watch product code FYA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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