# K212925: Disposable Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Henan Robestain Medical Products Co., Ltd.
- Decided: Dec 13, 2021 after 90 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
Disposable surgical gown is 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. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the disposable surgical gowns met the requirements for Level 3 classification.

Source page: https://510kreport.com/device/K212925
Methodology: https://510kreport.com/methodology