# K202139: Medical surgical mask

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Kingfa Sci. & Tech.Co., Ltd.
- Decided: Nov 20, 2020 after 112 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: 7 generations back to K874608 (1987). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093179: Medical Surgical Mask (HH1001), Respiratory Mask (HH1002), H&H Research Company (2010) Summary page 4.

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

## Indications for use
This product is indicated for infection control practices in the health care industry. When worn properly, the Medical Surgical Mask is intended to protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material.

Source page: https://510kreport.com/device/K202139
Methodology: https://510kreport.com/methodology