# K213450: Medical surgical mask (Black mask, Level 1 and Level 3)

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Kingfa Sci. & Tech.Co., Ltd.
- Decided: Apr 5, 2022 after 161 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: 8 generations back to K874608 (1987). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201622: Medical surgical mask, Guangdong Kingfa Sci. & Tech.Co., Ltd. (2020) Summary page 4.
- K202139: Medical surgical mask, Guangdong Kingfa Sci. & Tech.Co., Ltd. (2020) Summary page 5.

## Indications for use
Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and provided non-sterile.

Source page: https://510kreport.com/device/K213450
Methodology: https://510kreport.com/methodology