510(k) · Cleared
Recalled · Class II · 2025Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health200, LLC · FYA Gown, Surgical
Cleared on Mar 20, 2020 as substantially equivalent to K052824 (Kimberly-Clark Corp., 2006) after a 109-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 20, 2020
- Review
- 109 days
- Class
- Class II
- Product code
- FYA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K880382 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK880382 Kimberly-Clark Impervious Open Back GownKimberly-Clark Corp. · 1988
- 1 generation backK052824 Kimberly-Clark Procedure GownKimberly-Clark Corp. · 2006
- This deviceK193327 Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal…Cardinal Health200, LLC · 2020
- Descendant · cites it directly · 0 of its ownK214108 Medline Orbis Chemo Surgical GownMedline Industries, LP · 2022
Most influential descendants
Showing 1 of 1 · See all- K214108Medline Orbis Chemo Surgical GownMedline Industries, LP · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K880382 | Kimberly-Clark Impervious Open Back Gown | Kimberly-Clark Corp. | 1988 | — |
| −1 | K052824 | Kimberly-Clark Procedure Gown | Kimberly-Clark Corp. | 2006 | — |
| 0 (this device) | K193327 | Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health… | Cardinal Health200, LLC | 2020 | — |
| +1 | K214108 | Medline Orbis Chemo Surgical Gown | Medline Industries, LP | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (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 |
|---|---|---|---|
| * | K052824 | Kimberly-Clark Procedure GownSummary page 6…Surgical Apparel Common/Classification Name: Surgical Gown Product Codes: FYA Predicate Device: Kimberly-Clark Procedure Gown (K052824) Page 1 of 16 Description The Cardinal Health™ ChemoPlus™ Full Coverage… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K214108 | Medline Orbis Chemo Surgical Gown | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 12, 2025 | Class II | Z-0897-2026 | Under Investigation by firm | Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 2 companies; a new generation was cleared every 17.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K214108 (Medline Industries, LP, 2022) has gone furthest, with 0 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. 2020, 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 Cardinal Health™ ChemoPlus™ Full Coverage Gowns, Closed Back, are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling, and administration. The closed back gowns are single use, disposable medical devices provided sterile and non-sterile. The non-sterile, closed back gowns are not intended for use in the operating room. The Cardinal Health™ ChemoPlus™ Full Coverage Gowns, Open Back, are intended to…
Read the full statement (112 words)
The Cardinal Health™ ChemoPlus™ Full Coverage Gowns, Closed Back, are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling, and administration.
The closed back gowns are single use, disposable medical devices provided sterile and non-sterile. The non-sterile, closed back gowns are not intended for use in the operating room.
The Cardinal Health™ ChemoPlus™ Full Coverage Gowns, Open Back, are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling, and administration.
The open back gowns are single use, disposable medical devices provided non-sterile. The open back gown is nonprotective in the back. The open back gowns are not intended for use in the operating room.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193327 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193327: Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193327
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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