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
Allmed Medical (Hubei) Protective Products Co., Ltd. · FYA Gown, Surgical
Cleared on Sep 29, 2022 as substantially equivalent to K202706 (B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd., 2020) after a 115-day review. Its family tree reaches back 2 generations to 2020.
- Decided
- Sep 29, 2022
- Review
- 115 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 deviceK221637 Surgical Gown (Sterile); Surgical Gown (Non-sterile)Allmed Medical (Hubei) Protective Products Co., Ltd. · 2022
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) | K221637 | Surgical Gown (Sterile); Surgical Gown (Non-sterile) | Allmed Medical (Hubei) Protective Products Co., Ltd. | 2022 | — |
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…Classification Name: Gown, Surgical Classification: Class II Product code: FYA Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital C. Predicate device: K202706 B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., LTD. Trade Name: Surgical Gown (Sterile); Surgical Gown (Non-sterile) 1/7 === Page 5… | 2020 |
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 2 years and passes through 3 companies; a new generation was cleared every 1.7 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. 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?
The proposed 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…
Read the full statement (111 words)
The proposed 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.
Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according
to ISO 11135-1 prior to marketing to the end users and sterile surgical gowns are to be sold directly to the end users after
EtO sterilization validation to ISO 11135-1.
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/K221637 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221637: Surgical Gown (Sterile); Surgical Gown (Non-sterile).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221637
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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