# K253003: Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)

- Pathway: 510(k) (Traditional)
- Applicant: Hubei Xinxin Non-Woven Co., Ltd.
- Decided: Apr 20, 2026 after 213 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). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212869: Disposable Surgical Gown, Disposable Reinforced Surgical Gown, Fugou County Shenxiang Manufacturing Co., Ltd. (2021) Summary page 5.

## Indications for use
Surgical Gowns are intended to be worn by operation room personnel during surgical procedures or other invasive procedures tests to protect both the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This is single use, disposable device, provided non-sterile and sterile. Non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end users. Per ANSI/AAMI PB70:2022 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns meet the requirements for Level 3 classification, and the reinforced surgical gowns meet the requirements for Level 4 classification.

Source page: https://510kreport.com/device/K253003
Methodology: https://510kreport.com/methodology