510(k) · Cleared
ClearedSurgical Gown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xuchang Zhengde Environstar Medical Products Co.,L · FYA Gown, Surgical
Cleared on Mar 5, 2015 as substantially equivalent to K121152 (Jiangsu Guangda Medical Material, Co., Ltd., 2012) and 1 other predicate after a 275-day review. Its family tree reaches back 4 generations to 2009. 1 later device descends from it.
- Decided
- Mar 5, 2015
- Review
- 275 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K091097 (2009). 6 ancestors in all, the oldest K061308 (2006). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK091097 Promedical Surgical Gown, Models 18-301, 18-401 and 18-501Promedical Products Co., Ltd. · 2009
- 3 generations backK093115 Kimberly-Clark KC100 Surgical Gown, Model KC100Kimberly-Clark Corp. · 2010
- 2 generations backK102652 Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns…Gri Medical & Electronic Technology Co., Ltd. · 2011
- 1 generation backK121152 Surgical Gown, SMSJiangsu Guangda Medical Material, Co., Ltd. · 2012
- This deviceK141467 Surgical GownXuchang Zhengde Environstar Medical Products Co.,L · 2015
- Descendant · cites it directly · 0 of its ownK210215 Surgical GownsJiangsu Province Jianerkang Medical Dressing Co., Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K210215Surgical GownsJiangsu Province Jianerkang Medical Dressing Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K091097 | Promedical Surgical Gown, Models 18-301, 18-401 and 18-501 | Promedical Products Co., Ltd. | 2009 | — |
| −3 | K093115 | Kimberly-Clark KC100 Surgical Gown, Model KC100 | Kimberly-Clark Corp. | 2010 | — |
| −2 | K102652 | Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns, Fabric… | Gri Medical & Electronic Technology Co., Ltd. | 2011 | — |
| −1 | K121152 | Surgical Gown, SMS | Jiangsu Guangda Medical Material, Co., Ltd. | 2012 | — |
| 0 (this device) | K141467 | Surgical Gown | Xuchang Zhengde Environstar Medical Products Co.,L | 2015 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (2)
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 |
|---|---|---|---|
| * | K121152 | Surgical Gown, SMSSummary page 5…Surgical Gown Gown, Surgical Surgical apparel (21 CFR878.4040) Il FYA 1/6 Jiangsu Guangda Surgical Gown, Jiangsu Guangda Medical Material Co., Ltd, K121152. GRI's Surgical Gowns, GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD, K102652. These predicates have not been subject to a design-… | 2012 |
| * | K102652 | Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns, Fabric Reinforced…Summary page 5…/6 Jiangsu Guangda Surgical Gown, Jiangsu Guangda Medical Material Co., Ltd, K121152. GRI's Surgical Gowns, GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD, K102652. These predicates have not been subject to a design-related recall. No reference devices were used in this submission. V. DEVICE… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210215 | Surgical Gowns | 2021 | 0 |
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 6 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K210215 (Jiangsu Province Jianerkang Medical Dressing Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K121152.
How does its category compare?
All FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 gowns 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.
Models:
- Standard surgical gown, model number: ZD2514, ZD2515, ZD2517, ZD2519 and ZD2520;
- Reinforced surgical gown, model number: ZD2544, ZD2545, ZD2547, ZD2549 and ZD2550.
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/K141467 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141467: 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/K141467
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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