# K214088: Disposable Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
- Decided: Apr 12, 2022 after 105 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: 3 generations back to K020593 (2002). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173847: Disposable Ultra Reinforced Surgical Gown, Xiantao Rayxin Medical Products Co., Ltd. (2019) Summary page 5.

## Most influential descendants
- K222403: Surgical Gown (2023), 0 descendants of its own

## Indications for use
Disposable Surgical Gown is 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 material. In addition, this surgical gown meets the requirements of AAMI Level 4 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. It is single use, disposable medical devices, provided sterile.

Source page: https://510kreport.com/device/K214088
Methodology: https://510kreport.com/methodology