# K210518: Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Haidike Medical Products Co., Ltd.
- Decided: Jun 14, 2021 after 111 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 Surgical Face Mask is intended for single use by operation 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/K210518
Methodology: https://510kreport.com/methodology