# K202845: Bodygard SFS Surgical Gown Level 3

- Pathway: 510(k) (Traditional)
- Applicant: Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi
- Decided: Feb 24, 2022 after 517 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.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202844: Medical Surgical Gowns, Beijing Biosis Healing Biolog Ical Technology Co., Ltd. (2021). Cleared while this submission was under review Summary page 4.

## Indications for use
The Bodygard SFS Surgical Gown Level 3 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, Bodygard SFS Surgical Gown Level 3 met the requirements for Level 3 classification.

Source page: https://510kreport.com/device/K202845
Methodology: https://510kreport.com/methodology