# K221222: Surgical Face Mask (HNFM0304)

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Hua EN Industrial Co, Ltd.
- Decided: Jun 6, 2022 after 40 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: 11 generations back to K874608 (1987). 13 ancestors in all.
1 later device descends 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)
- K212097: Disposable medical surgical mask, Hebei Titans Hongsen Medical Technology Co., Ltd. (2021) Summary page 4.

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

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

Source page: https://510kreport.com/device/K221222
Methodology: https://510kreport.com/methodology