510(k) · Cleared
ClearedDisposable Surgical Gown, Disposable Reinforced Surgical Gown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fugou County Shenxiang Manufacturing Co., Ltd. · FYA Gown, Surgical
Cleared on Dec 13, 2021 as substantially equivalent to K211422 (Jiangsu Medplus Non-Woven Manufacturer Co., Ltd., 2021) and 2 other predicates after a 95-day review. Its family tree reaches back 6 generations to 1997. 3 later devices descend from it.
- Decided
- Dec 13, 2021
- Review
- 95 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K964142 (1997). 16 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK964142 Medline Disposable Surgical Drapes and GownsMedline Industries, Inc. · 1997 · Recalled
- 5 generations backK012186 Master & Frank Surgical Gowns (Sterile)Master & Frank Ent. Co., Ltd. · 2001
- 4 generations backK100971 Atek Surgical GownsHangzhou Atek Medical & Textile Co., Ltd. · 2010
- 3 generations backK120192 Disposable Surgical GownsWeihai Hongyu Nonwoven Fabric Products Co., Ltd. · 2012 · Recalled
- 2 generations backK172987 Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001…Gmax Industries, Inc. · 2018
- 1 generation backK211422 Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown…Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. · 2021
- This deviceK212869 Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK253003 Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical…Hubei Xinxin Non-Woven Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK222456 High Protection Surgical Gown3A Medical Products Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK221139 Bodygard SFS Surgical Gown Level 4Feliks Plastik Laminasyon VE Ambalaj Malzemeleri · 2022
Most influential descendants
Showing 3 of 3 · See all- K253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025)…Hubei Xinxin Non-Woven Co., Ltd. · 2026 · cites it directly0descendants
- K222456High Protection Surgical Gown3A Medical Products Co., Ltd. · 2023 · cites it directly0descendants
- K221139Bodygard SFS Surgical Gown Level 4Feliks Plastik Laminasyon VE Ambalaj Malzemeleri · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K964142 | Medline Disposable Surgical Drapes and Gowns | Medline Industries, Inc. | 1997 | 3 |
| −5 | K012186 | Master & Frank Surgical Gowns (Sterile) | Master & Frank Ent. Co., Ltd. | 2001 | — |
| −4 | K100971 | Atek Surgical Gowns | Hangzhou Atek Medical & Textile Co., Ltd. | 2010 | — |
| −3 | K120192 | Disposable Surgical Gowns | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2012 | 1 |
| −2 | K172987 | Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) | Gmax Industries, Inc. | 2018 | — |
| −1 | K211422 | Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3… | Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. | 2021 | — |
| 0 (this device) | K212869 | Disposable Surgical Gown, Disposable Reinforced Surgical Gown | Fugou County Shenxiang Manufacturing Co., Ltd. | 2021 | — |
| +1 | K253003 | Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown… | Hubei Xinxin Non-Woven Co., Ltd. | 2026 | — |
| +1 | K222456 | High Protection Surgical Gown | 3A Medical Products Co., Ltd. | 2023 | — |
| +1 | K221139 | Bodygard SFS Surgical Gown Level 4 | Feliks Plastik Laminasyon VE Ambalaj Malzemeleri | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K211422 | Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced…Summary page 7…masterbatch 5. Identification of Predicate Devices Predicate Device 1 510(k) Number: K211422 Product Name: Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown Predicate Device 2 510(k) Num… | 2021 |
| * | K192290 | 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB…Summary page 7…ice 1 510(k) Number: K211422 Product Name: Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown Predicate Device 2 510(k) Number: K192290 Product Name: SMS Standard Surgical Gown; SMS Surgical Gown with Reinforcement; BVB Surgical Gown; BVB Splicing Sur… | 2020 |
| * | K121152 | Surgical Gown, SMSSummary page 7…SMS Standard Surgical Gown; SMS Surgical Gown with Reinforcement; BVB Surgical Gown; BVB Splicing Surgical Gown Predicate Device 3 510(k) Number: K121152 Product Name: Surgical Gown 6. Summary of Clinical Testing No clinical study is included in this submission… | 2012 |
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 24 years and passes through 7 companies; a new generation was cleared every 4.8 years on median.
- 3 of the 16 ancestors have a recall of any class.
- Of its descendants, K253003 (Hubei Xinxin Non-Woven Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K211422.
How does its category compare?
All FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Disposable Surgical Gown and Disposable Reinforced Surgical Gown are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Disposable Surgical Gown ML515M45U met the requirements for Level 3 classification, Disposable Surgical Gown GD524ME65 and Disposable Reinforced Surgical Gown met the requirements of Level 4 classification.
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/K212869 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212869: Disposable Surgical Gown, Disposable Reinforced 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/K212869
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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