# K212861: Surgical Gown, Reinforced Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan Zonsen Medical Products Co., Ltd.
- Decided: Dec 15, 2021 after 98 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.
2 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211422: Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown, Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. (2021) Summary page 5.

## Most influential descendants
- K231510: Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) (2023), 1 descendant of its own
- K233183: Surgical Gown (40083) (2024), 0 descendants of its own

## Indications for use
Surgical Gown is intended to be worn by room personnel during surgical procedures or other invasive 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 sterile. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gown met the requirements for Level 2 classification, and the reinforced surgical gowns met the requirements for Level 3 classification.

Source page: https://510kreport.com/device/K212861
Methodology: https://510kreport.com/methodology