# K210215: Surgical Gowns

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Province Jianerkang Medical Dressing Co., Ltd.
- Decided: Jul 7, 2021 after 161 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: 5 generations back to K091097 (2009). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141467: Surgical Gown, Xuchang Zhengde Environstar Medical Products Co.,L (2015) Summary page 4.

## Indications for use
Surgical gown are devices that are intended to be worn by operating room personnel during surgical procedures 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/K210215
Methodology: https://510kreport.com/methodology