# K213844: Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Bayteks Teknik Tekstil San. VE Tic. A.S.
- Decided: Feb 16, 2023 after 434 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
Surgical gowns 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. This device is provided sterile. Per ASNI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the standard (non-reinforced) surgical gowns meet Level 2 classification and the reinforced surgical gowns meet Level 3 classification.

Source page: https://510kreport.com/device/K213844
Methodology: https://510kreport.com/methodology