510(k) · Cleared
ClearedSurgical Gown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xianning Marveldas Protective Articles Co., Ltd. · FYA Gown, Surgical
Cleared on Nov 16, 2022 as substantially equivalent to K121152 (Jiangsu Guangda Medical Material, Co., Ltd., 2012) after a 439-day review. Its family tree reaches back 4 generations to 2009.
- Decided
- Nov 16, 2022
- Review
- 439 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K091097 (2009). 6 ancestors in all, the oldest K061308 (2006). No later device cites it as a predicate yet.
- 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 deviceK212812 Surgical GownXianning Marveldas Protective Articles Co., Ltd. · 2022
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) | K212812 | Surgical Gown | Xianning Marveldas Protective Articles Co., Ltd. | 2022 | — |
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 |
|---|---|---|---|
| * | K121152 | Surgical Gown, SMSSummary page 4…ct Code: FYA Regulation Number: 21 CFR 878.4040 Classification: Class II Review Panel: General Hospital 3. Predicate Device Information: 510(k) Number: K121152 Predicate Device Name: Surgical Gown Manufacturer: Jiangsu Guangda Medical Material Co., Ltd. This predicate has not… | 2012 |
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 13 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.
- 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. 2022, 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 sterile, disposable, and single use 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. This device is sterilized using Ethylene Oxide (EO) following the Validation and routine control under ANSI/AAMI/ISO 11135 (2014).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212812 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212812: Surgical Gown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212812
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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