510(k) · Cleared
Recalled · Class II · 2026Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · FYA Gown, Surgical
Cleared on Jul 4, 2019 as substantially equivalent to K020593 (Allegiance Healthcare Corp., 2002) and 1 other predicate after an 84-day review. Its family tree reaches back 2 generations to 2002. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 4, 2019
- Review
- 84 days
- Class
- Class II
- Product code
- FYA
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K020593 (2002). 5 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK020593 Convertors SMS Polyolefin GownAllegiance Healthcare Corp. · 2002 · Recalled
- 1 generation backK170762 Cardinal Health Non-Reinforced Surgical GownCardinal Health200, LLC · 2017 · Recalled
- This deviceK190950 Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline…Medline Industries, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK261028 Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK250564 Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK220435 SEJONG Surgical Gown SoftSejong Healthcare Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK203548 EndoArmor™ + Surgical GownBoston Scientific Corporation · 2022
- Descendant · cites it directly · 0 of its ownK203539 Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico…Unicoglobal, Inc. · 2021
Most influential descendants
Showing 5 of 5 · See all- K261028Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd. · 2026 · cites it directly0descendants
- K250564Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)Yadu Medical (Henan) Co., Ltd. · 2025 · cites it directly0descendants
- K220435SEJONG Surgical Gown SoftSejong Healthcare Co., Ltd. · 2023 · cites it directly0descendants
- K203548EndoArmor™ + Surgical GownBoston Scientific Corporation · 2022 · cites it directly0descendants
- K203539Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical…Unicoglobal, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K020593 | Convertors SMS Polyolefin Gown | Allegiance Healthcare Corp. | 2002 | 23 |
| −1 | K170762 | Cardinal Health Non-Reinforced Surgical Gown | Cardinal Health200, LLC | 2017 | 17 |
| 0 (this device) | K190950 | Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3… | Medline Industries, Inc. | 2019 | — |
| +1 | K261028 | Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd. | 2026 | — |
| +1 | K250564 | Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd. | 2025 | — |
| +1 | K220435 | SEJONG Surgical Gown Soft | Sejong Healthcare Co., Ltd. | 2023 | — |
| +1 | K203548 | EndoArmor™ + Surgical Gown | Boston Scientific Corporation | 2022 | — |
| +1 | K203539 | Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3… | Unicoglobal, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K020593 | Convertors SMS Polyolefin GownSummary page 5…510(k) Premarket Submission Northfield, IL 60093 All information on this page is confidential Predicate Device K020593 Allegiance Healthcare Converters SMS Polyolefin Gowns (Primary Predicate) K170762 Cardinal Health™ Non-Reinforced (Secondary Pred… | 2002 |
| * | K170762 | Cardinal Health Non-Reinforced Surgical GownSummary page 5…All information on this page is confidential Predicate Device K020593 Allegiance Healthcare Converters SMS Polyolefin Gowns (Primary Predicate) K170762 Cardinal Health™ Non-Reinforced (Secondary Predicate) Device Description The Medline Level 2 Surgical Gown (Eclipse Non Reinfor… | 2017 |
What descends from it? (5)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261028 | Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) | 2026 | 0 |
| K250564 | Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) | 2025 | 0 |
| K220435 | SEJONG Surgical Gown Soft | 2023 | 0 |
| K203548 | EndoArmor™ + Surgical Gown | 2022 | 0 |
| K203539 | Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical… | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 7, 2026 | Class II | Z-1424-2026 | Under Investigation by firm | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues… |
| Jan 7, 2026 | Class II | Z-2129-2026 | Process control | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 15.2 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K261028 (Yadu Medical (Henan) Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K020593.
How does its category compare?
All FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Medline Level 2 Surgical Gown (Eclipse Non Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced & Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of…
Read the full statement (179 words)
The Medline Level 2 Surgical Gown (Eclipse Non Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced & Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter.
The Medline Level 2 Surgical Gown and the Medline Level 3 Surgical Gowns meet the respective level requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
The Medline Level 2 Surgical Gown and the Medline Level 3 Surgical Gowns have been validated using an ethylene oxide (EtO) sterilization process. The Medline Level 2 Surgical Gown and the Medline Level 3 Surgical Gowns are also sold as bulk single-use, non-sterile, to repackager/relabeler establishments for further packaging and sterilization using the validated EtO sterilization method according to ISO 11135-1 prior to being provided to the end user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190950 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190950: Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190950
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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