# K212726: Disposable Medical Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Hubei Huaqiang High-Tech Co., Ltd.
- Decided: Mar 23, 2022 after 208 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)
- K202904: Surgical Face Mask, Jiangxi Feilikang Medical Technology Co., Ltd. (2021) Summary page 5.

## Indications for use
The Disposable Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Disposable Medical Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device(s), provided sterile.

Source page: https://510kreport.com/device/K212726
Methodology: https://510kreport.com/methodology