510(k) · Cleared
ClearedCardinal HealthTM Poly-Coated Open-Back Protective Gown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health200, LLC · QPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
Cleared on Apr 26, 2019 as substantially equivalent to K952115 (American Threshold Industries, Inc., 1995) after a 203-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Apr 26, 2019
- Review
- 203 days
- Class
- Class II
- Product code
- QPC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952115 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK952115 Barrier Gown, Kool-Gard Backless GownAmerican Threshold Industries, Inc. · 1995
- This deviceK182830 Cardinal HealthTM Poly-Coated Open-Back Protective GownCardinal Health200, LLC · 2019
- Descendant · cites it directly · 0 of its ownK212464 Dukal Corporation AAMI Level 4 Open-Back Protective GownDukal Corporation · 2022
Most influential descendants
Showing 1 of 1 · See all- K212464Dukal Corporation AAMI Level 4 Open-Back Protective GownDukal Corporation · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952115 | Barrier Gown, Kool-Gard Backless Gown | American Threshold Industries, Inc. | 1995 | — |
| 0 (this device) | K182830 | Cardinal HealthTM Poly-Coated Open-Back Protective Gown | Cardinal Health200, LLC | 2019 | — |
| +1 | K212464 | Dukal Corporation AAMI Level 4 Open-Back Protective Gown | Dukal Corporation | 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 QPC? 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 QPC device
- #1 K262007 PRIMED AAMI Level 3 Open Back Gownsscore 12.9 · 4 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 |
|---|---|---|---|
| * | K952115 | Barrier Gown, Kool-Gard Backless GownSummary page 5…pparel Common/Classification Name: Surgical Isolation Gown Product Code: FYC Predicate Device: Kool-Gard Backless Protective Gown (K952115) Page 1 of 7 510(k) SU… | 1995 |
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 |
|---|---|---|---|
| K212464 | Dukal Corporation AAMI Level 4 Open-Back Protective Gown | 2022 | 0 |
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, K212464 (Dukal Corporation, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QPC devicesQPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QPC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QPC
Too few QPC 510(k)s in any year since 2007 to give a median.
Recalls per year · QPC
No recall names QPC since 2007.
Adverse event reports per year · QPC
No MAUDE report names QPC since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Cardinal Health™ Poly-Coated Open-Back Protective Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. Not intended for use in the operating room.
The proposed Cardinal Health™ Poly-Coated Open-Back Protective Gown meets the barrier protection requirements of AAMI Level 4 per ANSIVJAAMI PB70:2012. Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities, but has an open back which is non-protective.
The Cardinal Health™ Poly-Coated Open-Back Protective Gowns is a single use. disposable medical device provided non-sterile.
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/K182830 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182830: Cardinal HealthTM Poly-Coated Open-Back Protective Gown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182830
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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