# K214087: Medical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Hubei Medlink Healthcare Co., Ltd.
- Decided: Mar 8, 2022 after 71 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: 5 generations back to K874608 (1987). 7 ancestors in all.
2 later devices descend 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)
- K201729: Medical Mask, Zhende Medical Co., Ltd. (2020) Summary page 5.

## Most influential descendants
- K222809: Medical Disposable Face Masks (2023), 1 descendant of its own
- K240258: Disposable Medical Face Mask (M643BE) (2024), 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 material. The face 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/K214087
Methodology: https://510kreport.com/methodology