# K211077: Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Wujiang Tutaike Textiles & Finishing Co., Ltd.
- Decided: Oct 7, 2021 after 178 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)
- K202844: Medical Surgical Gowns, Beijing Biosis Healing Biolog Ical Technology Co., Ltd. (2021) Summary page 4.

## Indications for use
The Surgical Gowns 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.

Source page: https://510kreport.com/device/K211077
Methodology: https://510kreport.com/methodology