# K242689: AAMI Level 4 Protective; Gown

- Pathway: 510(k) (Traditional)
- Applicant: Azac Group
- Decided: Jan 13, 2025 after 129 days
- Product code: QPC (Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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.

Source page: https://510kreport.com/device/K242689
Methodology: https://510kreport.com/methodology