# K212464: Dukal Corporation AAMI Level 4 Open-Back Protective Gown

- Pathway: 510(k) (Traditional)
- Applicant: Dukal Corporation
- Decided: Mar 30, 2022 after 236 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
Longest line of descent: 2 generations back to K952115 (1995). 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)
- K182830: Cardinal HealthTM Poly-Coated Open-Back Protective Gown, Cardinal Health200, LLC (2019) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K212464
Methodology: https://510kreport.com/methodology