# K203415: Surgical Isolation Gown

- Pathway: 510(k) (Traditional)
- Applicant: Yanbian Pacific Textile Co., Ltd.
- Decided: May 20, 2021 after 182 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.
1 later device descends from it; 1 cites it directly.
0 of 5 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.

## Most influential descendants
- K212422: Disposable Surgical Isolation Gown (2022), 0 descendants of its own

## Indications for use
The Surgical Isolation Gown is intended to protect 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 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 Gown is a single use, disposable medical device provided non-sterile.

Source page: https://510kreport.com/device/K203415
Methodology: https://510kreport.com/methodology