510(k) · Cleared
ClearedAAMI Level 4 Protective; Gown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Azac Group · QPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
Cleared on Jan 13, 2025 after a 129-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 13, 2025
- Review
- 129 days
- Class
- Class II
- Product code
- QPC
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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. 2025, 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 AAMI Level 4 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 AAMI Level 4 Protective Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI 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 AAMI Level 4 Protective Gown is a single use, disposable medical device and is provided non-sterile.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K242689 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242689: AAMI Level 4 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/K242689
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026