510(k) · Cleared
ClearedSurgical Gown, Reinforced Surgical Gown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wuhan Zonsen Medical Products Co., Ltd. · FYA Gown, Surgical
Cleared on Dec 15, 2021 as substantially equivalent to K211422 (Jiangsu Medplus Non-Woven Manufacturer Co., Ltd., 2021) after a 98-day review. Its family tree reaches back 6 generations to 1997. 2 later devices descend from it.
- Decided
- Dec 15, 2021
- Review
- 98 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K964142 (1997). 9 ancestors in all. 2 later devices descend from it, 1 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 deviceK212861 Surgical Gown, Reinforced Surgical GownWuhan Zonsen Medical Products Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK231510 Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown…Xiantao Zhibo Non-Woven Products Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK233183 Surgical Gown (40083)Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. · 2024
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 |
|---|---|---|---|---|---|
| −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) | K212861 | Surgical Gown, Reinforced Surgical Gown | Wuhan Zonsen Medical Products Co., Ltd. | 2021 | — |
| +1 | K231510 | Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) | Xiantao Zhibo Non-Woven Products Co., Ltd. | 2023 | — |
| +2 | K233183 | Surgical Gown (40083) | Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K211422 | Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced…Summary page 5…Classification Name: Gown, Surgical Classification: Class II Product code: FYA Regulation Number: 878.4040 Review Panel: Surgical Apparel C. Predicate device: K211422 Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown Jiangsu Medplus Non-woven… | 2021 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231510 | Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) | 2023 | 1 |
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.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K231510 (Xiantao Zhibo Non-Woven Products Co., Ltd., 2023) has gone furthest, with 1 descendant 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?
Surgical Gown is intended to be worn by room personnel during surgical procedures or other invasive tests to protect both the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This is single use, disposable device, provided sterile.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gown met the requirements for Level 2 classification, and the reinforced surgical gowns met the requirements for Level 3 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/K212861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212861: Surgical Gown, 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/K212861
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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