510(k) · Cleared
ClearedKimberly-Clark Procedure Gown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kimberly-Clark Corp. · FYA Gown, Surgical
Cleared on May 2, 2006 as substantially equivalent to K880382 (Kimberly-Clark Corp., 1988) after a 209-day review. Its family tree reaches back 1 generation to 1988. 2 later devices descend from it.
- Decided
- May 2, 2006
- Review
- 209 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K880382 (1988). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK880382 Kimberly-Clark Impervious Open Back GownKimberly-Clark Corp. · 1988
- This deviceK052824 Kimberly-Clark Procedure GownKimberly-Clark Corp. · 2006
- Descendant · cites it directly · 1 of its ownK193327 Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal…Cardinal Health200, LLC · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK214108 Medline Orbis Chemo Surgical GownMedline Industries, LP · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880382 | Kimberly-Clark Impervious Open Back Gown | Kimberly-Clark Corp. | 1988 | — |
| 0 (this device) | K052824 | Kimberly-Clark Procedure Gown | Kimberly-Clark Corp. | 2006 | — |
| +1 | K193327 | Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health… | Cardinal Health200, LLC | 2020 | 1 |
| +2 | K214108 | Medline Orbis Chemo Surgical Gown | Medline Industries, LP | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K880382 | Kimberly-Clark Impervious Open Back GownSummary page 1…CFR 878.4040) 3. Predicate Device The Kimberly-Clark Procedure Gown is substantially equivalent to the Kimberly-Clark Impervious Open Back Gown cleared under K880382. 4. Intended Use of the Device The Kimberly-Clark Procedure Gown is a non-sterile, disposable, single use item of app… | 1988 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193327 | Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus… | 2020 | 1 |
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?
- Its one ancestor has no recall.
- Of its descendants, K193327 (Cardinal Health200, LLC, 2020) has gone furthest, with 1 descendant 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 Kimberly-Clark Procedure Gown is a non-sterile, disposable, single use item of apparel intended to be worn by healthcare professionals during the preparation and administration of selected chemotherapy drugs. The gown is not intended to be worn during surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052824 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052824: Kimberly-Clark Procedure Gown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052824
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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