# K211399: Sterile Level 3 Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Barco Tekstil Sanayi VE Ticaret A.S.
- Decided: Jul 22, 2022 after 443 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: 2 generations back to K192290 (2020). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202706: Surgical Gown (Sterile), Surgical Gown (Non-sterile), B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. (2020) Summary page 4.

## Indications for use
The Sterile Level 3 Surgical Gown is 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, the surgical gowns met the requirements for Level 3 classification.

Source page: https://510kreport.com/device/K211399
Methodology: https://510kreport.com/methodology