# K120192: Disposable Surgical Gowns

- Pathway: 510(k) (Traditional)
- Applicant: Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
- Decided: Oct 16, 2012 after 267 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K964142 (1997). 5 ancestors in all.
20 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100971: Atek Surgical Gowns, Hangzhou Atek Medical & Textile Co., Ltd. (2010) Summary page 5.

## Most influential descendants
- K172987: Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) (2018), 19 descendants of its own
- K211422: Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown (2021), 11 descendants of its own
- K212869: Disposable Surgical Gown, Disposable Reinforced Surgical Gown (2021), 3 descendants of its own
- K212861: Surgical Gown, Reinforced Surgical Gown (2021), 2 descendants of its own
- K202844: Medical Surgical Gowns (2021), 2 descendants of its own

## Recalls of this device
- Sep 1, 2022 · Class II · Z-0242-2023: Surgical gowns recalled due to gown fabric failing to pass the hydrostatic pressure test so the fabric does not provide the protection needed in a level 3 surgical gown, i.e., blood and other fluid ma

## Indications for use
Disposable Surgical Gowns, which are blue colored and EQ sterilized, are indicated to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. It could achieve Level 3 Barrier Performance as per AAMI P870:2003. It is for single use only.

Source page: https://510kreport.com/device/K120192
Methodology: https://510kreport.com/methodology