# K212398: Surgical Face Mask (Non-sterile)

- Pathway: 510(k) (Traditional)
- Applicant: Hubei Kimsoul Industrial Co., Ltd.
- Decided: Dec 15, 2021 after 135 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: 3 generations back to K911334 (1991). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211105: Ear-Friendly Mask, Ray Co., Ltd. (2021) Summary page 4.

## Most influential descendants
- K222335: Surgical Mask (2022), 0 descendants of its own

## Indications for use
The masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for adult 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/K212398
Methodology: https://510kreport.com/methodology