510(k) · Cleared
Recalled · Class II · 2021Convertors SMS Polyolefin Gown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allegiance Healthcare Corp. · FYA Gown, Surgical
Cleared on Mar 18, 2002 after a 24-day review. The FDA summary names its predicate without a number. 20 later devices descend from it. It has been recalled 23 times.
- Decided
- Mar 18, 2002
- Review
- 24 days
- Class
- Class II
- Product code
- FYA
- Recalls
- 23
- Predicates
- 0
20 later devices descend from it, 2 citing it directly.
- This deviceK020593 Convertors SMS Polyolefin GownAllegiance Healthcare Corp. · 2002
- Descendant · cites it directly · 19 of its ownK170762 Cardinal Health Non-Reinforced Surgical GownCardinal Health200, LLC · 2017 · Recalled
- Descendant · cites it directly · 5 of its ownK190950 Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline…Medline Industries, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 2 of its ownK212591 Disposable Surgical GownSuzhou Janee Medical Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 2 of its ownK211509 Surgical GownHubei Wanli Protective Products Co., Ltd. · 2021
- Descendant · 2 generations on · 2 of its ownK173847 Disposable Ultra Reinforced Surgical GownXiantao Rayxin Medical Products Co., Ltd. · 2019
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K170762Cardinal Health Non-Reinforced Surgical GownCardinal Health200, LLC · 2017 · cites it directly19descendants
- K190950Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown…Medline Industries, Inc. · 2019 · cites it directly5descendants
- K212591Disposable Surgical GownSuzhou Janee Medical Technology Co., Ltd. · 2022 · 2 generations on2descendants
- K211509Surgical GownHubei Wanli Protective Products Co., Ltd. · 2021 · 2 generations on2descendants
- K173847Disposable Ultra Reinforced Surgical GownXiantao Rayxin Medical Products Co., Ltd. · 2019 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020593 | Convertors SMS Polyolefin Gown | Allegiance Healthcare Corp. | 2002 | — |
| +1 | 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 |
| +2 | K212591 | Disposable Surgical Gown | Suzhou Janee Medical Technology Co., Ltd. | 2022 | — |
| +2 | K211509 | Surgical Gown | Hubei Wanli Protective Products Co., Ltd. | 2021 | — |
| +2 | K173847 | Disposable Ultra Reinforced Surgical Gown | Xiantao Rayxin Medical Products Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | — | Convertors®SMS Polyolefin Standard, Fabric and Poly-reinforced Gowns Named without a submission number |
What descends from it? (20)
See all 202 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 2, 2021 | Class II | Z-0373-2022 | Process control | Potential for open packaging seals compromising the sterility of the surgical gowns |
| Nov 2, 2021 | Class II | Z-0374-2022 | Process control | Potential for open packaging seals compromising the sterility of the surgical gowns |
| Nov 2, 2021 | Class II | Z-0378-2022 | Process control | Potential for open packaging seals compromising the sterility of the surgical gowns |
| Nov 2, 2021 | Class II | Z-0372-2022 | Process control | Potential for open packaging seals compromising the sterility of the surgical gowns |
| Nov 2, 2021 | Class II | Z-0375-2022 | Process control | Potential for open packaging seals compromising the sterility of the surgical gowns |
| Nov 2, 2021 | Class II | Z-0376-2022 | Process control | Potential for open packaging seals compromising the sterility of the surgical gowns |
| Nov 2, 2021 | Class II | Z-0377-2022 | Process control | Potential for open packaging seals compromising the sterility of the surgical gowns |
| Jan 11, 2020 | Class II | Z-1011-2020 | Vendor change control | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Jan 11, 2020 | Class II | Z-1013-2020 | Vendor change control | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Jan 11, 2020 | Class II | Z-1022-2020 | Vendor change control | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Jan 11, 2020 | Class II | Z-1024-2020 | Vendor change control | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Jan 11, 2020 | Class II | Z-1040-2020 | Vendor change control | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Jan 11, 2020 | Class II | Z-1010-2020 | Vendor change control | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Jan 11, 2020 | Class II | Z-1014-2020 | Vendor change control | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Jan 11, 2020 | Class II | Z-1023-2020 | Vendor change control | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Jan 11, 2020 | Class II | Z-1026-2020 | Vendor change control | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Jan 11, 2020 | Class II | Z-1027-2020 | Vendor change control | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Jan 11, 2020 | Class II | Z-1034-2020 | Vendor change control | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Jan 11, 2020 | Class II | Z-1035-2020 | Vendor change control | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Jan 11, 2020 | Class II | Z-1036-2020 | Vendor change control | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Jan 11, 2020 | Class II | Z-1009-2020 | Vendor change control | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Jan 11, 2020 | Class II | Z-1012-2020 | Vendor change control | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
| Jan 11, 2020 | Class II | Z-1025-2020 | Vendor change control | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. |
The 5 latest of 23 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K170762 (Cardinal Health200, LLC, 2017) has gone furthest, with 19 descendants of its own.
How does its category compare?
All FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Convertors®SMS Polyolefin Gowns are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
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/K020593 · printed Nov 3, 2026
Cite this page
510(k) Report. “K020593: Convertors SMS Polyolefin Gown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K020593
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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