510(k) · Cleared
ClearedDisposable Surgical Gowns
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chongqing Litai Fashion Group Limited Company · FYC Gown, Isolation, Surgical
Cleared on Nov 13, 2021 as substantially equivalent to K202310 (Wildcat Ppe, LLC, 2021) after a 242-day review. Its family tree reaches back 3 generations to 1995. 3 later devices descend from it.
- Decided
- Nov 13, 2021
- Review
- 242 days
- Class
- Class II
- Product code
- FYC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K952116 (1995). 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK952116 Cover GownAmerican Threshold Industries, Inc. · 1995
- 2 generations backK160339 Cardinal Health Isolation GownCardinal Health200, LLC · 2016 · Recalled
- 1 generation backK202310 Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical…Wildcat Ppe, LLC · 2021
- This deviceK210785 Disposable Surgical GownsChongqing Litai Fashion Group Limited Company · 2021
- Descendant · cites it directly · 0 of its ownK223467 Disposable Isolation GownNanning Tecbod Biological Technology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK223304 Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Technology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK223411 Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Techology Co., Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See all- K223467Disposable Isolation GownNanning Tecbod Biological Technology Co., Ltd. · 2023 · cites it directly0descendants
- K223304Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Technology Co., Ltd. · 2023 · cites it directly0descendants
- K223411Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Techology Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952116 | Cover Gown | American Threshold Industries, Inc. | 1995 | — |
| −2 | K160339 | Cardinal Health Isolation Gown | Cardinal Health200, LLC | 2016 | 2 |
| −1 | K202310 | Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation… | Wildcat Ppe, LLC | 2021 | — |
| 0 (this device) | K210785 | Disposable Surgical Gowns | Chongqing Litai Fashion Group Limited Company | 2021 | — |
| +1 | K223467 | Disposable Isolation Gown | Nanning Tecbod Biological Technology Co., Ltd. | 2023 | — |
| +1 | K223304 | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) | Xiamen Probtain Medical Technology Co., Ltd. | 2023 | — |
| +1 | K223411 | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) | Xiamen Probtain Medical Techology Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 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 FYC? 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 FYC device
- #1 K190306 AMD Ritmed AssureWear VersaGownscore 14.0 · 2 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 |
|---|---|---|---|
| * | K202310 | Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full BackSummary page 4…fication Name: Surgical Isolation Gown Classification: Class II Product code: FYC Regulation Number: 21 CFR 878.4040 Review Panel: Surgical Apparel C. Predicate device: K202310 Wildcat PE Surgical Isolation Gown Full Back Wildcat PPE, LLC D. Intended use of the device: Disposable Surgical Isolation Gowns… | 2021 |
What descends from it? (3)
3 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 26 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K223467 (Nanning Tecbod Biological Technology Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K202310.
How does its category compare?
All FYC devicesFYC Gown, Isolation, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · FYC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FYC
95in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FYC
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FYC
3in 2025
MAUDE reports naming product code FYC, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 7 | 182 | 0 | 0 |
| 2022 | 10 | 229 | 0 | 0 |
| 2023 | 4 | 95 | 0 | 1 |
| 2024 | 1 | — | 2 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Disposable Surgical Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. This Disposable Surgical Isolation Gowns 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). The Disposable Surgical Isolation Gowns are single use, disposable medical devices; provided non-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/K210785 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210785: Disposable Surgical Gowns.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210785
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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