# K221977: Disposable Surgical Gown (G4003)

- Pathway: 510(k) (Traditional)
- Applicant: Xiantao Topmed Nonwoven Protective Products Co., Ltd.
- Decided: Oct 20, 2022 after 107 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)
- K211809: Surgical Gown, Wuhan Dymex Healthcare Co., Ltd. (2021) Summary page 4.

## Indications for use
The Disposable 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. In addition, this surgical gown meets the requirements of AAI 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 (AAI PB70). This is a single use, disposable device, provided sterile. The surgical gown has six sizes - S, M, L, XL, XXL and XXXL.

Source page: https://510kreport.com/device/K221977
Methodology: https://510kreport.com/methodology