# K212471: Medical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Haian Medigauze Co., Ltd.
- Decided: Nov 4, 2021 after 90 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: 6 generations back to K874608 (1987). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160269: Surgical Face Masks (Ear loops and Tie-on), San-M Package Co., Ltd. (2016) Summary page 4.

## Most influential descendants
- K221838: Surgical Face Mask  (HNFM0103) (2022), 0 descendants of its own

## Indications for use
The medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single-use and provided non-sterile.

Source page: https://510kreport.com/device/K212471
Methodology: https://510kreport.com/methodology