# K203161: Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan Raytex Protection Co., Ltd.
- Decided: Jan 20, 2022 after 454 days
- Product code: FXX (Mask, 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: 7 generations back to K874608 (1987). 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)
- K202061: Medical Face mask, Jiangsu Province Jianerkang Medical Dressing Co., Ltd. (2020). Cleared while this submission was under review Summary page 4.

## Indications for use
When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate material. This device is non-sterile and for single use only.

Source page: https://510kreport.com/device/K203161
Methodology: https://510kreport.com/methodology