510(k) · Cleared
ClearedUnico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unicoglobal, Inc. · FYA Gown, Surgical
Cleared on Dec 10, 2021 as substantially equivalent to K190950 (Medline Industries, Inc., 2019) after a 372-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Dec 10, 2021
- Review
- 372 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K020593 (2002). No later device cites it as a predicate yet.
- Root · 3 generations backK020593 Convertors SMS Polyolefin GownAllegiance Healthcare Corp. · 2002 · Recalled
- 2 generations backK170762 Cardinal Health Non-Reinforced Surgical GownCardinal Health200, LLC · 2017 · Recalled
- 1 generation backK190950 Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline…Medline Industries, Inc. · 2019 · Recalled
- This deviceK203539 Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico…Unicoglobal, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K020593 | Convertors SMS Polyolefin Gown | Allegiance Healthcare Corp. | 2002 | 23 |
| −2 | K170762 | Cardinal Health Non-Reinforced Surgical Gown | Cardinal Health200, LLC | 2017 | 17 |
| −1 | K190950 | Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3… | Medline Industries, Inc. | 2019 | 2 |
| 0 (this device) | K203539 | Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3… | Unicoglobal, Inc. | 2021 | — |
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 |
|---|---|---|---|
| * | K190950 | Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown…Summary page 4…Gown (Sirus Non-Reinforced) Medline Level 3 Surgical Gown (Sirus Fabric Reinforced) Medline Level 3 Surgical Gown (Aurora Non -Reinforced & Aurora Fabric Rein (K190950) by Medline Industries, Inc. Page 1 of 6 5. Description: The sub… | 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 19 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 3 ancestors have a recall of any class.
- 4 other devices also cite its predicate K190950.
How does its category compare?
All FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Unico Global Level 3 Surgical Gown (Film-reinforced SMS) and Unico Global Level 3 Surgical Gown (PP+PE) 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 Unico Global Level 3 Surgical Gowns meets the respective level requirements of ANSI/AAMI PB70:2012 level 3 liquid barrier…
Read the full statement (154 words)
The Unico Global Level 3 Surgical Gown (Film-reinforced SMS) and Unico Global Level 3 Surgical Gown (PP+PE) 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 Unico Global Level 3 Surgical Gowns meets the respective level requirements of ANSI/AAMI PB70:2012 level 3 liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
The Unico Global Level 3 Surgical Gown (Film-reinforced SMS) and Unico Global Level 3 Surgical Gown (PP+PE) are single use, disposable medical devices; provided sterile or non-sterile. 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 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/K203539 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203539: Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203539
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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