# K212812: Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Xianning Marveldas Protective Articles Co., Ltd.
- Decided: Nov 16, 2022 after 439 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: 4 generations back to K091097 (2009). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121152: Surgical Gown, SMS, Jiangsu Guangda Medical Material, Co., Ltd. (2012) Summary page 4.

## Indications for use
Surgical gowns are sterile, disposable, and single use devices that are intended 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. This device is sterilized using Ethylene Oxide (EO) following the Validation and routine control under ANSI/AAMI/ISO 11135 (2014).

Source page: https://510kreport.com/device/K212812
Methodology: https://510kreport.com/methodology