510(k) · Cleared
ClearedSurgical Gown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Fuzelong Hygiene Material Co., Ltd. · FYA Gown, Surgical
Cleared on Jan 26, 2023 as substantially equivalent to K214088 (Weihai Hongyu Nonwoven Fabric Products Co., Ltd., 2022) after a 170-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Jan 26, 2023
- Review
- 170 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K020593 (2002). No later device cites it as a predicate yet.
- Root · 4 generations backK020593 Convertors SMS Polyolefin GownAllegiance Healthcare Corp. · 2002 · Recalled
- 3 generations backK170762 Cardinal Health Non-Reinforced Surgical GownCardinal Health200, LLC · 2017 · Recalled
- 2 generations backK173847 Disposable Ultra Reinforced Surgical GownXiantao Rayxin Medical Products Co., Ltd. · 2019
- 1 generation backK214088 Disposable Surgical GownWeihai Hongyu Nonwoven Fabric Products Co., Ltd. · 2022
- This deviceK222403 Surgical GownGuangzhou Fuzelong Hygiene Material Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K020593 | Convertors SMS Polyolefin Gown | Allegiance Healthcare Corp. | 2002 | 23 |
| −3 | K170762 | Cardinal Health Non-Reinforced Surgical Gown | Cardinal Health200, LLC | 2017 | 17 |
| −2 | K173847 | Disposable Ultra Reinforced Surgical Gown | Xiantao Rayxin Medical Products Co., Ltd. | 2019 | — |
| −1 | K214088 | Disposable Surgical Gown | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2022 | — |
| 0 (this device) | K222403 | Surgical Gown | Guangzhou Fuzelong Hygiene Material Co., Ltd. | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FYA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FYA device
- #1 K211422 Level 2 Standard Surgical Gown, Level 3…score 20.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K214088 | Disposable Surgical GownSummary page 4…cal apparel 4.0 Predicate device information Manufacturer: Weihai Hongyu Nonwoven Fabric Products Co., Ltd. Device: Disposable Surgical Gown 510(k) number: K214088 Product code: FYA Regulation number: 21 CFR 878.4040 1 510(k) Summar… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 4 ancestors have a recall of any class.
How does its category compare?
All FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · FYA
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FYA
210in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FYA
1in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · FYA
14in 2025
MAUDE reports naming product code FYA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 110 | 2 | 8 |
| 2008 | 4 | 207 | 0 | 3 |
| 2009 | 6 | 98 | 0 | 18 |
| 2010 | 4 | 128 | 2 | 9 |
| 2011 | 8 | 141 | 0 | 16 |
| 2012 | 4 | 202 | 1 | 43 |
| 2013 | 2 | — | 0 | 71 |
| 2014 | 5 | 120 | 9 (9) | 42 |
| 2015 | 3 | 275 | 0 | 59 |
| 2016 | 3 | 155 | 0 | 43 |
| 2017 | 4 | 111 | 0 | 66 |
| 2018 | 2 | — | 1 | 98 |
| 2019 | 5 | 105 | 0 | 38 |
| 2020 | 7 | 114 | 40 | 31 |
| 2021 | 17 | 163 | 11 | 15 |
| 2022 | 24 | 177 | 2 | 4 |
| 2023 | 12 | 190 | 1 | 12 |
| 2024 | 5 | 163 | 0 | 27 |
| 2025 | 4 | 210 | 1 | 14 |
| 2026 | 9 | 198 | 2 | — |
What is it indicated for?
The Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. In addition, this surgical gown meets the requirements of AAMI Level 4 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices, provided sterile.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222403 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222403: Surgical Gown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222403
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026