# K212869: Disposable Surgical Gown, Disposable Reinforced Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Fugou County Shenxiang Manufacturing Co., Ltd.
- Decided: Dec 13, 2021 after 95 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). 16 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 20 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 7.
- K192290: 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown, Xuchang Zhengde Environstar Medical Products Co., Ltd. (2020) Summary page 7.
- K121152: Surgical Gown, SMS, Jiangsu Guangda Medical Material, Co., Ltd. (2012) Summary page 7.

## Most influential descendants
- 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) (2026), 0 descendants of its own
- K222456: High Protection Surgical Gown (2023), 0 descendants of its own
- K221139: Bodygard SFS Surgical Gown Level 4 (2022), 0 descendants of its own

## Indications for use
Disposable Surgical Gown and Disposable Reinforced Surgical Gown are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Disposable Surgical Gown ML515M45U met the requirements for Level 3 classification, Disposable Surgical Gown GD524ME65 and Disposable Reinforced Surgical Gown met the requirements of Level 4 classification.

Source page: https://510kreport.com/device/K212869
Methodology: https://510kreport.com/methodology