510(k) · Cleared
ClearedComfort Gown, Safewear Gown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xuchang Zhengde Environstar Medical Products Co., Ltd. · FYA Gown, Surgical
Cleared on Dec 21, 2022 as substantially equivalent to K192290 (Xuchang Zhengde Environstar Medical Products Co., Ltd., 2020) and 1 other predicate after a 372-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Dec 21, 2022
- Review
- 372 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K964142 (1997). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK964142 Medline Disposable Surgical Drapes and GownsMedline Industries, Inc. · 1997 · Recalled
- 4 generations backK012186 Master & Frank Surgical Gowns (Sterile)Master & Frank Ent. Co., Ltd. · 2001
- 3 generations backK100971 Atek Surgical GownsHangzhou Atek Medical & Textile Co., Ltd. · 2010
- 2 generations backK120192 Disposable Surgical GownsWeihai Hongyu Nonwoven Fabric Products Co., Ltd. · 2012 · Recalled
- 1 generation backK172987 Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001…Gmax Industries, Inc. · 2018
- This deviceK213893 Comfort Gown, Safewear GownXuchang Zhengde Environstar Medical Products Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K964142 | Medline Disposable Surgical Drapes and Gowns | Medline Industries, Inc. | 1997 | 3 |
| −4 | K012186 | Master & Frank Surgical Gowns (Sterile) | Master & Frank Ent. Co., Ltd. | 2001 | — |
| −3 | K100971 | Atek Surgical Gowns | Hangzhou Atek Medical & Textile Co., Ltd. | 2010 | — |
| −2 | K120192 | Disposable Surgical Gowns | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2012 | 1 |
| −1 | K172987 | Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) | Gmax Industries, Inc. | 2018 | — |
| 0 (this device) | K213893 | Comfort Gown, Safewear Gown | Xuchang Zhengde Environstar Medical Products 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 |
|---|---|---|---|
| * | K192290 | 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB…Summary page 6…us Surgical Gown M, L, XL, XXL, XXXL Reinforced 3 5. Identification of Predicate Devices 6. Predicate Device 1 510(k) Number: K192290 Product Name: SMS Standard Surgical Gown, SMS Surgical Gown with Reinforcement, BVB Surgical Gown, BVB Splicing… | 2020 |
| * | K172987 | Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)Summary page 6…tandard Surgical Gown, SMS Surgical Gown with Reinforcement, BVB Surgical Gown, BVB Splicing Surgical Gown Predicate Device 2 510(k) Number: K172987 Product Name: Surgical Gown (used AE series as predicate device) 7. Non-Clinical Test Conclusion Non… | 2018 |
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 6 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 4 other devices also cite its predicate K192290.
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, Comfort Gown met the requirements for Level 1 and Level 2 Standard Surgical…
Read the full statement (152 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, Comfort Gown met the requirements for Level 1 and Level 2 Standard Surgical Gown classifications, and Safewear Gown met the requirements for Level 3 Standard Surgical Gown, Level 3 Standard Plus Surgical Gown, Level 3 Reinforced Surgical Gown and Level 3 Reinforced Plus Surgical Gown classifications.
The gowns are provided sterile and non-sterile. Non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213893 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213893: Comfort Gown, Safewear Gown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213893
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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