510(k) · Cleared
ClearedDisposable Surgical Gown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Janee Medical Technology Co., Ltd. · FYA Gown, Surgical
Cleared on Jan 11, 2022 as substantially equivalent to K170762 (Cardinal Health200, LLC, 2017) after a 148-day review. Its family tree reaches back 2 generations to 2002. 2 later devices descend from it.
- Decided
- Jan 11, 2022
- Review
- 148 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K020593 (2002). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK020593 Convertors SMS Polyolefin GownAllegiance Healthcare Corp. · 2002 · Recalled
- 1 generation backK170762 Cardinal Health Non-Reinforced Surgical GownCardinal Health200, LLC · 2017 · Recalled
- This deviceK212591 Disposable Surgical GownSuzhou Janee Medical Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK223401 Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Techology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK221717 Disposable Surgical Gown UM-148Unimax Medical Products Co., Ltd. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K020593 | Convertors SMS Polyolefin Gown | Allegiance Healthcare Corp. | 2002 | 23 |
| −1 | K170762 | Cardinal Health Non-Reinforced Surgical Gown | Cardinal Health200, LLC | 2017 | 17 |
| 0 (this device) | K212591 | Disposable Surgical Gown | Suzhou Janee Medical Technology Co., Ltd. | 2022 | — |
| +1 | K223401 | Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) | Xiamen Probtain Medical Techology Co., Ltd. | 2023 | — |
| +1 | K221717 | Disposable Surgical Gown UM-148 | Unimax Medical Products Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
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 |
|---|---|---|---|
| * | K170762 | Cardinal Health Non-Reinforced Surgical GownSummary page 4…Classification Name: Gown, Surgical Classification: Class II Product code: FYA Regulation Number: 878.4040 Review Panel: Surgical Apparel C. Predicate device: K170762 Cardinal Health™ Non-Reinforced Surgical Gown Cardinal Health 200, LLC D. Intended use of the device: The Disposable Surgi… | 2017 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 3 companies; a new generation was cleared every 15.2 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K223401 (Xiamen Probtain Medical Techology Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K170762.
How does its category compare?
All FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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. In addition, this surgical gown meets the requirements of AAMI Level 3 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).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/K212591 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212591: Disposable Surgical Gown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212591
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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