510(k) · Cleared
ClearedSurgical Gown (Sterile), Surgical Gown (Non-sterile)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · FYA Gown, Surgical
Cleared on Dec 31, 2020 as substantially equivalent to K192290 (Xuchang Zhengde Environstar Medical Products Co., Ltd., 2020) after a 106-day review. Its family tree reaches back 1 generation to 2020. 5 later devices descend from it.
- Decided
- Dec 31, 2020
- Review
- 106 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K192290 (2020). 5 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK192290 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with…Xuchang Zhengde Environstar Medical Products Co., Ltd. · 2020
- This deviceK202706 Surgical Gown (Sterile), Surgical Gown (Non-sterile)B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK221559 Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3Stringking · 2023
- Descendant · cites it directly · 0 of its ownK213844 Surgical GownBayteks Teknik Tekstil San. VE Tic. A.S. · 2023
- Descendant · cites it directly · 0 of its ownK221637 Surgical Gown (Sterile); Surgical Gown (Non-sterile)Allmed Medical (Hubei) Protective Products Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK211399 Sterile Level 3 Surgical GownBarco Tekstil Sanayi VE Ticaret A.S. · 2022
- Descendant · cites it directly · 0 of its ownK210355 Surgical Gown, Model: surgical gown-hp-3Weihai Dishang Medical Technology Co., Ltd. · 2021
Most influential descendants
Showing 5 of 5 · See all- K221559Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3Stringking · 2023 · cites it directly0descendants
- K213844Surgical GownBayteks Teknik Tekstil San. VE Tic. A.S. · 2023 · cites it directly0descendants
- K221637Surgical Gown (Sterile); Surgical Gown (Non-sterile)Allmed Medical (Hubei) Protective Products Co., Ltd. · 2022 · cites it directly0descendants
- K211399Sterile Level 3 Surgical GownBarco Tekstil Sanayi VE Ticaret A.S. · 2022 · cites it directly0descendants
- K210355Surgical Gown, Model: surgical gown-hp-3Weihai Dishang Medical Technology Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K192290 | 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g… | Xuchang Zhengde Environstar Medical Products Co., Ltd. | 2020 | — |
| 0 (this device) | K202706 | Surgical Gown (Sterile), Surgical Gown (Non-sterile) | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 2020 | — |
| +1 | K221559 | Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3 | Stringking | 2023 | — |
| +1 | K213844 | Surgical Gown | Bayteks Teknik Tekstil San. VE Tic. A.S. | 2023 | — |
| +1 | K221637 | Surgical Gown (Sterile); Surgical Gown (Non-sterile) | Allmed Medical (Hubei) Protective Products Co., Ltd. | 2022 | — |
| +1 | K211399 | Sterile Level 3 Surgical Gown | Barco Tekstil Sanayi VE Ticaret A.S. | 2022 | — |
| +1 | K210355 | Surgical Gown, Model: surgical gown-hp-3 | Weihai Dishang Medical Technology Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K192290 | 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB…Summary page 5…, the proposed devices meet the requirements for Level 3 classification. 6. Identification of Predicate Device 510K Number: K192290 Product Name: 50g SMS Standard Surgical Gown; 45g SMS Surgical Gown with Reinforc… | 2020 |
| † | K172987 | Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) | 2018 |
What descends from it? (5)
5 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?
How does its category compare?
All FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 3 classification.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202706 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202706: Surgical Gown (Sterile), Surgical Gown (Non-sterile).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202706
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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