# K220528: Surgical Isolation Cover Gown

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan Dymex Healthcare Co., Ltd.
- Decided: Jun 10, 2022 after 106 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)
- K171535: Surgical Isolation Gown, Jingzhou Haixin Green Cross Medical Products Co., Ltd. (2018) Summary page 5.

## Indications for use
The Surgical Isolation Cover Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Cover Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Surgical Isolation Cover Gown is a single use, disposable medical device provided non-sterile.

Source page: https://510kreport.com/device/K220528
Methodology: https://510kreport.com/methodology