# K141467: Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Xuchang Zhengde Environstar Medical Products Co.,L
- Decided: Mar 5, 2015 after 275 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: 4 generations back to K091097 (2009). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121152: Surgical Gown, SMS, Jiangsu Guangda Medical Material, Co., Ltd. (2012) Summary page 5.
- K102652: Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns, Fabric Reinforced Surgical Gowns, Gri Medical & Electronic Technology Co., Ltd. (2011) Summary page 5.

## Most influential descendants
- K210215: Surgical Gowns (2021), 0 descendants of its own

## Indications for use
Surgical gowns 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. Models: - Standard surgical gown, model number: ZD2514, ZD2515, ZD2517, ZD2519 and ZD2520; - Reinforced surgical gown, model number: ZD2544, ZD2545, ZD2547, ZD2549 and ZD2550.

Source page: https://510kreport.com/device/K141467
Methodology: https://510kreport.com/methodology