# K210785: Disposable Surgical Gowns

- Pathway: 510(k) (Traditional)
- Applicant: Chongqing Litai Fashion Group Limited Company
- Decided: Nov 13, 2021 after 242 days
- Product code: FYC (Gown, Isolation, 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: 3 generations back to K952116 (1995). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202310: Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back, Wildcat Ppe, LLC (2021) Summary page 4.

## Most influential descendants
- K223467: Disposable Isolation Gown (2023), 0 descendants of its own
- K223304: Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) (2023), 0 descendants of its own
- K223411: Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) (2023), 0 descendants of its own

## Indications for use
Disposable Surgical Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. This Disposable Surgical Isolation Gowns meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Disposable Surgical Isolation Gowns are single use, disposable medical devices; provided non-sterile.

Source page: https://510kreport.com/device/K210785
Methodology: https://510kreport.com/methodology