510(k) · Cleared
ClearedDukal Corporation AAMI Level 4 Open-Back Protective Gown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dukal Corporation · QPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
Cleared on Mar 30, 2022 as substantially equivalent to K182830 (Cardinal Health200, LLC, 2019) after a 236-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Mar 30, 2022
- Review
- 236 days
- Class
- Class II
- Product code
- QPC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K952115 (1995). No later device cites it as a predicate yet.
- Root · 2 generations backK952115 Barrier Gown, Kool-Gard Backless GownAmerican Threshold Industries, Inc. · 1995
- 1 generation backK182830 Cardinal HealthTM Poly-Coated Open-Back Protective GownCardinal Health200, LLC · 2019
- This deviceK212464 Dukal Corporation AAMI Level 4 Open-Back Protective GownDukal Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952115 | Barrier Gown, Kool-Gard Backless Gown | American Threshold Industries, Inc. | 1995 | — |
| −1 | K182830 | Cardinal HealthTM Poly-Coated Open-Back Protective Gown | Cardinal Health200, LLC | 2019 | — |
| 0 (this device) | K212464 | Dukal Corporation AAMI Level 4 Open-Back Protective Gown | Dukal Corporation | 2022 | — |
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 |
|---|---|---|---|
| * | K182830 | Cardinal HealthTM Poly-Coated Open-Back Protective GownSummary page 4…Cardinal Health Poly-Coated Open-Back Protective Gowns (level 4) • 510k #K182830, cleared on 4/26/2019 13. Device Description: Dukal AAMI Level 4 Open-Back Protective Gowns are… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 23.6 years on median.
- None of the 2 ancestors has a recall.
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. 2022, 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 Dukal AAMI Level 4 Open-Back Protective Gowns are intended to protect health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. These gowns are not intended for use in the operating room.
The Dukal AAMI Level 4 Open-Back Protective Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70, 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.
These gowns are single use, disposable medical devices 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/K212464 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212464: Dukal Corporation AAMI Level 4 Open-Back Protective Gown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212464
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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