# K212649: Disposable Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Lyncmed Medical Technology (Beijing) Co., Ltd.
- Decided: Oct 25, 2022 after 428 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 K970835 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202029: Medical Surgical Mask, Beijing Biosis Healing Biolog Ical Technology Co., Ltd. (2020) Summary page 5.

## Indications for use
The disposable surgical face mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

Source page: https://510kreport.com/device/K212649
Methodology: https://510kreport.com/methodology