# K211538: Protect X Level 3 Isolation Gown

- Pathway: 510(k) (Traditional)
- Applicant: Azac Group
- Decided: Nov 17, 2021 after 183 days
- Product code: FYC (Gown, Isolation, Surgical)
- 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
Longest line of descent: 2 generations back to K925077 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160337: Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns, Bam Corporation Limited (2017) Summary page 4.

## Indications for use
The AZAC Protect X Level 3, Single Use, Non-Sterile, 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 AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown gown meets the barrier protection requirements of AAMI Level 3 per ANSI/AAMI PB70:2012 — Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities. The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown is a single use, disposable medical device and is provided non-sterile.

Source page: https://510kreport.com/device/K211538
Methodology: https://510kreport.com/methodology