510(k) · Cleared
Cleared35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Winner Medical Co., Ltd. · FYA Gown, Surgical
Cleared on Sep 19, 2022 as substantially equivalent to K211422 (Jiangsu Medplus Non-Woven Manufacturer Co., Ltd., 2021) and 1 other predicate after an 88-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Sep 19, 2022
- Review
- 88 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K964142 (1997). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK964142 Medline Disposable Surgical Drapes and GownsMedline Industries, Inc. · 1997 · Recalled
- 5 generations backK012186 Master & Frank Surgical Gowns (Sterile)Master & Frank Ent. Co., Ltd. · 2001
- 4 generations backK100971 Atek Surgical GownsHangzhou Atek Medical & Textile Co., Ltd. · 2010
- 3 generations backK120192 Disposable Surgical GownsWeihai Hongyu Nonwoven Fabric Products Co., Ltd. · 2012 · Recalled
- 2 generations backK172987 Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001…Gmax Industries, Inc. · 2018
- 1 generation backK211422 Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown…Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. · 2021
- This deviceK221819 35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical…Winner Medical Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K964142 | Medline Disposable Surgical Drapes and Gowns | Medline Industries, Inc. | 1997 | 3 |
| −5 | K012186 | Master & Frank Surgical Gowns (Sterile) | Master & Frank Ent. Co., Ltd. | 2001 | — |
| −4 | K100971 | Atek Surgical Gowns | Hangzhou Atek Medical & Textile Co., Ltd. | 2010 | — |
| −3 | K120192 | Disposable Surgical Gowns | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2012 | 1 |
| −2 | K172987 | Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) | Gmax Industries, Inc. | 2018 | — |
| −1 | K211422 | Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3… | Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. | 2021 | — |
| 0 (this device) | K221819 | 35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g… | Winner Medical Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2020 | 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? (2)
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 |
|---|---|---|---|
| * | K211422 | Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced…Summary page 7…3 5. Identification of Predicate Devices Predicate Device 1 510K Number: K211422 Trade Name: Level 2 Standard Surgical Gown Level 3 Standard Surgical Gown… | 2021 |
| * | K192290 | 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB…Summary page 7…ical Gown Level 3 Standard Surgical Gown Level 3 Reinforced Surgical Gown Predicate Device 2 510K Number: K192290 Trade Name: SMS Standard Surgical Gown SMS Surgical Gown with Reinforcement… | 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 25 years and passes through 7 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 5 other devices also cite its predicate K211422.
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 gown is 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, 35g Standard SMMS Surgical Gown met the requirements for Level 2…
Read the full statement (154 words)
Surgical gown is 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, 35g Standard SMMS Surgical Gown met the requirements for Level 2 classification; 35g Reinforced SMMS Surgical Gown, 43g Standard SMMS Surgical Gown, 43g Reinforced SMMS Surgical Gown, 50g Standard SMMS Surgical Gown and 50g Reinforced SMMS Surgical Gown met the requirements for Level 3 classification; BVB Surgical gown met the requirements for Level 4 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 as stated in the FDA summary.
https://510kreport.com/device/K221819 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221819: 35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221819
Report an extraction error
Are you the manufacturer?
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