# K182830: Cardinal HealthTM Poly-Coated Open-Back Protective Gown

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health200, LLC
- Decided: Apr 26, 2019 after 203 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: 1 generation back to K952115 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952115: Barrier Gown, Kool-Gard Backless Gown, American Threshold Industries, Inc. (1995) Summary page 5.

## Most influential descendants
- K212464: Dukal Corporation AAMI Level 4 Open-Back Protective Gown (2022), 0 descendants of its own

## Indications for use
The Cardinal Health™ Poly-Coated Open-Back 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 proposed Cardinal Health™ Poly-Coated Open-Back Protective Gown meets the barrier protection requirements of AAMI Level 4 per ANSIVJAAMI 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 Cardinal Health™ Poly-Coated Open-Back Protective Gowns is a single use. disposable medical device provided non-sterile.

Source page: https://510kreport.com/device/K182830
Methodology: https://510kreport.com/methodology