510(k) · Cleared
ClearedSurgical Gown, SMS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Guangda Medical Material, Co., Ltd. · FYA Gown, Surgical
Cleared on Dec 12, 2012 as substantially equivalent to K102652 (Gri Medical & Electronic Technology Co., Ltd., 2011) after a 240-day review. Its family tree reaches back 3 generations to 2009. 7 later devices descend from it.
- Decided
- Dec 12, 2012
- Review
- 240 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K091097 (2009). 5 ancestors in all, the oldest K061308 (2006). 7 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK091097 Promedical Surgical Gown, Models 18-301, 18-401 and 18-501Promedical Products Co., Ltd. · 2009
- 2 generations backK093115 Kimberly-Clark KC100 Surgical Gown, Model KC100Kimberly-Clark Corp. · 2010
- 1 generation backK102652 Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns…Gri Medical & Electronic Technology Co., Ltd. · 2011
- This deviceK121152 Surgical Gown, SMSJiangsu Guangda Medical Material, Co., Ltd. · 2012
- Descendant · cites it directly · 3 of its ownK212869 Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK141467 Surgical GownXuchang Zhengde Environstar Medical Products Co.,L · 2015
- Descendant · 2 generations on · 0 of its ownK253003 Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical…Hubei Xinxin Non-Woven Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK222456 High Protection Surgical Gown3A Medical Products Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK212812 Surgical GownXianning Marveldas Protective Articles Co., Ltd. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K212869Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd. · 2021 · cites it directly3descendants
- K141467Surgical GownXuchang Zhengde Environstar Medical Products Co.,L · 2015 · cites it directly1descendant
- K253003Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025)…Hubei Xinxin Non-Woven Co., Ltd. · 2026 · 2 generations on0descendants
- K222456High Protection Surgical Gown3A Medical Products Co., Ltd. · 2023 · 2 generations on0descendants
- K212812Surgical GownXianning Marveldas Protective Articles Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K091097 | Promedical Surgical Gown, Models 18-301, 18-401 and 18-501 | Promedical Products Co., Ltd. | 2009 | — |
| −2 | K093115 | Kimberly-Clark KC100 Surgical Gown, Model KC100 | Kimberly-Clark Corp. | 2010 | — |
| −1 | K102652 | Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns, Fabric… | Gri Medical & Electronic Technology Co., Ltd. | 2011 | — |
| 0 (this device) | K121152 | Surgical Gown, SMS | Jiangsu Guangda Medical Material, Co., Ltd. | 2012 | — |
| +1 | K212869 | Disposable Surgical Gown, Disposable Reinforced Surgical Gown | Fugou County Shenxiang Manufacturing Co., Ltd. | 2021 | — |
| +1 | K141467 | Surgical Gown | Xuchang Zhengde Environstar Medical Products Co.,L | 2015 | — |
| +2 | K253003 | Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown… | Hubei Xinxin Non-Woven Co., Ltd. | 2026 | — |
| +2 | K222456 | High Protection Surgical Gown | 3A Medical Products Co., Ltd. | 2023 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 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? (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 |
|---|---|---|---|
| * | K102652 | Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns, Fabric Reinforced…Summary page 1…mon Name: Gown, Surgical Classification: Surgical Apparel, FYA, Class 2 (878.4040) 5. Predicate Device: GRI MEDICAL Surgical Gowns (K102652) 6. Device Description: Jiangsu Guangda's Disposable XLarge Reinforced Surgical Gowns, Model Number GD-SG-01, are made from S… | 2011 |
What descends from it? (7)
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 3 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K212869 (Fugou County Shenxiang Manufacturing Co., Ltd., 2021) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K102652.
How does its category compare?
All FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Jiangsu Guangda's Reinforced Surgical Gowns are non-sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
This product may be sterilized using Ethylene Oxide (EO) following the validation and routine control under ANSI/AAMI/ISO 11135.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121152 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121152: Surgical Gown, SMS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121152
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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