510(k) · Cleared
ClearedSurgical Gowns
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Province Jianerkang Medical Dressing Co., Ltd. · FYA Gown, Surgical
Cleared on Jul 7, 2021 as substantially equivalent to K141467 (Xuchang Zhengde Environstar Medical Products Co.,L, 2015) after a 161-day review. Its family tree reaches back 5 generations to 2009.
- Decided
- Jul 7, 2021
- Review
- 161 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K091097 (2009). 7 ancestors in all, the oldest K061308 (2006). No later device cites it as a predicate yet.
- Root · 5 generations backK091097 Promedical Surgical Gown, Models 18-301, 18-401 and 18-501Promedical Products Co., Ltd. · 2009
- 4 generations backK093115 Kimberly-Clark KC100 Surgical Gown, Model KC100Kimberly-Clark Corp. · 2010
- 3 generations backK102652 Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns…Gri Medical & Electronic Technology Co., Ltd. · 2011
- 2 generations backK121152 Surgical Gown, SMSJiangsu Guangda Medical Material, Co., Ltd. · 2012
- 1 generation backK141467 Surgical GownXuchang Zhengde Environstar Medical Products Co.,L · 2015
- This deviceK210215 Surgical GownsJiangsu Province Jianerkang Medical Dressing Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K091097 | Promedical Surgical Gown, Models 18-301, 18-401 and 18-501 | Promedical Products Co., Ltd. | 2009 | — |
| −4 | K093115 | Kimberly-Clark KC100 Surgical Gown, Model KC100 | Kimberly-Clark Corp. | 2010 | — |
| −3 | K102652 | Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns, Fabric… | Gri Medical & Electronic Technology Co., Ltd. | 2011 | — |
| −2 | K121152 | Surgical Gown, SMS | Jiangsu Guangda Medical Material, Co., Ltd. | 2012 | — |
| −1 | K141467 | Surgical Gown | Xuchang Zhengde Environstar Medical Products Co.,L | 2015 | — |
| 0 (this device) | K210215 | Surgical Gowns | Jiangsu Province Jianerkang Medical Dressing Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K141467 | Surgical GownSummary page 4…Names: Surgical apparel Model: Regulation number 21 CFR 878.4040 Regulation Class: 2 Product Code: FYA 3. PREDICATE DEVICE K141467, Surgical gown XuChang ZhengDe Environstar Medical Products Co., Ltd This predicate has not been subject to a design‐related rec… | 2015 |
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 12 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
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 are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
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/K210215 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210215: 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/K210215
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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