# K252301: Henan Yadu Level 4 Surgical Gowns (Reinforced)

- Pathway: 510(k) (Traditional)
- Applicant: Yadu Medical (Henan) Co., Ltd.
- Decided: Feb 4, 2026 after 195 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: 2 generations back to K080795 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182172: Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora), Medline Industries, Inc. (2019) Summary page 5.

## Indications for use
Henan Yadu Level 4 Surgical Gown (Reinforced) are sterile, single-use surgical apparel intended to be used by operating room personnel during surgical operations and other invasive examinations to provide a liquid and microbial barrier for patients and medical staff. These products meet the Level 4 liquid barrier performance requirements of ANSI/AAMI PB70:2022 "Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities."

Source page: https://510kreport.com/device/K252301
Methodology: https://510kreport.com/methodology