510(k) · Cleared
Recalled · Class II · 2024Cardinal Health Isolation Gown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health200, LLC · FYC Gown, Isolation, Surgical
Cleared on Jul 28, 2016 as substantially equivalent to K952116 (American Threshold Industries, Inc., 1995) after a 171-day review. Its family tree reaches back 1 generation to 1995. 16 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 28, 2016
- Review
- 171 days
- Class
- Class II
- Product code
- FYC
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952116 (1995). 16 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK952116 Cover GownAmerican Threshold Industries, Inc. · 1995
- This deviceK160339 Cardinal Health Isolation GownCardinal Health200, LLC · 2016
- Descendant · cites it directly · 6 of its ownK190306 AMD Ritmed AssureWear VersaGownAmd Medicom, Inc. · 2020
- Descendant · cites it directly · 5 of its ownK202310 Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical…Wildcat Ppe, LLC · 2021
- Descendant · 2 generations on · 3 of its ownK210785 Disposable Surgical GownsChongqing Litai Fashion Group Limited Company · 2021
- Descendant · 2 generations on · 1 of its ownK203415 Surgical Isolation GownYanbian Pacific Textile Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK171535 Surgical Isolation GownJingzhou Haixin Green Cross Medical Products Co., Ltd. · 2018
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K190306AMD Ritmed AssureWear VersaGownAmd Medicom, Inc. · 2020 · cites it directly6descendants
- K202310Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full BackWildcat Ppe, LLC · 2021 · cites it directly5descendants
- K210785Disposable Surgical GownsChongqing Litai Fashion Group Limited Company · 2021 · 2 generations on3descendants
- K203415Surgical Isolation GownYanbian Pacific Textile Co., Ltd. · 2021 · 2 generations on1descendant
- K171535Surgical Isolation GownJingzhou Haixin Green Cross Medical Products Co., Ltd. · 2018 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952116 | Cover Gown | American Threshold Industries, Inc. | 1995 | — |
| 0 (this device) | K160339 | Cardinal Health Isolation Gown | Cardinal Health200, LLC | 2016 | — |
| +1 | K190306 | AMD Ritmed AssureWear VersaGown | Amd Medicom, Inc. | 2020 | — |
| +1 | K202310 | Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation… | Wildcat Ppe, LLC | 2021 | — |
| +2 | K210785 | Disposable Surgical Gowns | Chongqing Litai Fashion Group Limited Company | 2021 | — |
| +2 | K203415 | Surgical Isolation Gown | Yanbian Pacific Textile Co., Ltd. | 2021 | — |
| +1 | K171535 | Surgical Isolation Gown | Jingzhou Haixin Green Cross Medical Products Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 0 |
| 2023 | 4 | 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 FYC? 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 FYC device
- #1 K190306 AMD Ritmed AssureWear VersaGownscore 14.0 · 2 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 |
|---|---|---|---|
| * | K952116 | Cover GownSummary page 4…on Gown Product Code: FYC Classification Name: Surgical Isolation Gown Predicate Device: Kool-Gard Procedure/Cover Gown, K952116 Page 1 of 7 Description The Cardi… | 1995 |
What descends from it? (16)
See all 164 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 1, 2024 | Class II | Z-0675-2025 | Nonconforming Material/Component | Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection… |
| Nov 1, 2024 | Class II | Z-0674-2025 | Nonconforming Material/Component | Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K190306 (Amd Medicom, Inc., 2020) has gone furthest, with 6 descendants of its own.
How does its category compare?
All FYC devicesFYC Gown, Isolation, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · FYC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FYC
95in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FYC
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FYC
3in 2025
MAUDE reports naming product code FYC, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 7 | 182 | 0 | 0 |
| 2022 | 10 | 229 | 0 | 0 |
| 2023 | 4 | 95 | 0 | 1 |
| 2024 | 1 | — | 2 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Cardinal HealthTM Isolation Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Cardinal HealthTM Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Cardinal HealthTM Isolation Gown is a single use, disposable medical device provided non-sterile.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160339 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160339: Cardinal Health Isolation Gown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160339
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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