510(k) · Cleared
ClearedDisposable Surgical Gowns (S,M,L,XL,XXL,XXXL)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xiamen Probtain Medical Techology Co., Ltd. · FYA Gown, Surgical
Cleared on Mar 7, 2023 as substantially equivalent to K212591 (Suzhou Janee Medical Technology Co., Ltd., 2022) after a 118-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Mar 7, 2023
- Review
- 118 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K020593 (2002). No later device cites it as a predicate yet.
- Root · 3 generations backK020593 Convertors SMS Polyolefin GownAllegiance Healthcare Corp. · 2002 · Recalled
- 2 generations backK170762 Cardinal Health Non-Reinforced Surgical GownCardinal Health200, LLC · 2017 · Recalled
- 1 generation backK212591 Disposable Surgical GownSuzhou Janee Medical Technology Co., Ltd. · 2022
- This deviceK223401 Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Techology Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K020593 | Convertors SMS Polyolefin Gown | Allegiance Healthcare Corp. | 2002 | 23 |
| −2 | K170762 | Cardinal Health Non-Reinforced Surgical Gown | Cardinal Health200, LLC | 2017 | 17 |
| −1 | K212591 | Disposable Surgical Gown | Suzhou Janee Medical Technology Co., Ltd. | 2022 | — |
| 0 (this device) | K223401 | Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) | Xiamen Probtain Medical Techology 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 |
|---|---|---|---|
| * | K212591 | Disposable Surgical GownSummary page 4…own, Surgical Classification: Class II Product code: FYA Regulation Number: 21 CFR 878.4040 Review Panel: Surgical Apparel C. Predicate device: K212591 Disposable Surgical Gown Suzhou JaneE Medical Technology Co., Ltd.… | 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 4 companies; a new generation was cleared every 4.6 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K212591.
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 Disposable Surgical Gowns are 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 matter. This is a single use, disposable device, provided
sterile.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K223401 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223401: Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223401
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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