# K261028: Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)

- Pathway: 510(k) (Traditional)
- Applicant: Yadu Medical (Henan) Co., Ltd.
- Decided: Aug 7, 2026 after 130 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: 3 generations back to K020593 (2002). 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)
- K190950: Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced), Medline Industries, Inc. (2019) Summary page 5.

## Indications for use
Level2 Surgical Gown is sterile, single-use surgical apparel intended to be worn by healthcare professionals during surgical procedures to provide barrier protection against the transfer of microorganisms, body fluids, and particulate material for both patients and healthcare personnel. The product meets the Level 2 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/K261028
Methodology: https://510kreport.com/methodology