# K212097: Disposable medical surgical mask

- Pathway: 510(k) (Traditional)
- Applicant: Hebei Titans Hongsen Medical Technology Co., Ltd.
- Decided: Aug 18, 2021 after 43 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: 10 generations back to K874608 (1987). 12 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202511: Disposable Medical Surgical Mask, Improve Medical (Hunan) Co., Ltd. (2021) Summary page 5.

## Most influential descendants
- K221222: Surgical Face Mask (HNFM0304) (2022), 1 descendant of its own
- K222651: Surgical Face Mask (2022), 0 descendants of its own

## 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 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 non-sterile.

Source page: https://510kreport.com/device/K212097
Methodology: https://510kreport.com/methodology