# K220092: YADU Surgical Gowns

- Pathway: 510(k) (Traditional)
- Applicant: Henan Yadu Industrial Co., Ltd.
- Decided: Oct 7, 2022 after 268 days
- Product code: FYA (Gown, 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: 6 generations back to K964142 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211422: Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown, Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. (2021) Summary page 5.

## Indications for use
YADU Surgical Gowns are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The surgical gowns meet the requirements for Level 2 and Level 3 classification Per ANSI/AAMI PB-70.

Source page: https://510kreport.com/device/K220092
Methodology: https://510kreport.com/methodology