# K214116: AAMI4 Isolation Gown

- Pathway: 510(k) (Traditional)
- Applicant: Hubei Xinxin Non-Woven Co., Ltd.
- Decided: Oct 11, 2022 after 285 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: 3 generations back to K952116 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190306: AMD Ritmed AssureWear VersaGown, Amd Medicom, Inc. (2020) Summary page 5.

## Indications for use
The AAMI4 Isolation 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 AAMI4 Isolation Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB 70:2012, Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities. The AAMI4 Isolation Gown is a single use, disposable medical device provided non-sterile.

Source page: https://510kreport.com/device/K214116
Methodology: https://510kreport.com/methodology