# K201622: Medical surgical mask

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Kingfa Sci. & Tech.Co., Ltd.
- Decided: Nov 24, 2020 after 162 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 K970835 (1997). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153409: Protect U Guard Earloop and Tie-On Mask (Blue, White or Green), Protect U Guard, LLC (2016) Summary page 5.

## Most influential descendants
- K231155: Biodegradable Medical surgical mask (2023), 0 descendants of its own
- K213450: Medical surgical mask (Black mask, Level 1 and Level 3) (2022), 0 descendants of its own

## 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/K201622
Methodology: https://510kreport.com/methodology