# K231510: Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)

- Pathway: 510(k) (Traditional)
- Applicant: Xiantao Zhibo Non-Woven Products Co., Ltd.
- Decided: Aug 22, 2023 after 89 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: 7 generations back to K964142 (1997). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212861: Surgical Gown, Reinforced Surgical Gown, Wuhan Zonsen Medical Products Co., Ltd. (2021) Summary page 4.

## Most influential descendants
- K233183: Surgical Gown (40083) (2024), 0 descendants of its own

## Indications for use
The Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. This is a single use, disposable device, provided sterile. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Surgical Gown and Reinforced Surgical Gown met the requirements for Level 3 classification.

Source page: https://510kreport.com/device/K231510
Methodology: https://510kreport.com/methodology