510(k) · Cleared
ClearedSurgical Gown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayteks Teknik Tekstil San. VE Tic. A.S. · FYA Gown, Surgical
Cleared on Feb 16, 2023 as substantially equivalent to K202706 (B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd., 2020) after a 434-day review. Its family tree reaches back 2 generations to 2020.
- Decided
- Feb 16, 2023
- Review
- 434 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K192290 (2020). No later device cites it as a predicate yet.
- Root · 2 generations backK192290 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with…Xuchang Zhengde Environstar Medical Products Co., Ltd. · 2020
- 1 generation backK202706 Surgical Gown (Sterile), Surgical Gown (Non-sterile)B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · 2020
- This deviceK213844 Surgical GownBayteks Teknik Tekstil San. VE Tic. A.S. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K192290 | 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g… | Xuchang Zhengde Environstar Medical Products Co., Ltd. | 2020 | — |
| −1 | K202706 | Surgical Gown (Sterile), Surgical Gown (Non-sterile) | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 2020 | — |
| 0 (this device) | K213844 | Surgical Gown | Bayteks Teknik Tekstil San. VE Tic. A.S. | 2023 | — |
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 |
|---|---|---|---|
| * | K202706 | Surgical Gown (Sterile), Surgical Gown (Non-sterile)Summary page 4…II Review Panel: General Hospital 5. Legally Marketed Predicate and Reference Devices Predicate Device name: Surgical Gown 510(k) number: K202706 Page 1 of 6… | 2020 |
| † | K190950 | Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown… | 2019 |
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 3 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K202706.
How does its category compare?
All FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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.
This device is provided sterile.
Per ASNI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the standard (non-reinforced) surgical gowns meet Level 2 classification and the reinforced surgical gowns meet Level 3 classification.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213844 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213844: 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/K213844
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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