# K202424: Surgical Mask-Models CR02-2, CR02

- Pathway: 510(k) (Traditional)
- Applicant: Foshan Xinbao Technology Co., Ltd.
- Decided: Mar 31, 2021 after 218 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 K874608 (1987). 8 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160269: Surgical Face Masks (Ear loops and Tie-on), San-M Package Co., Ltd. (2016) Summary page 4.

## Most influential descendants
- K220067: Medical Surgery Mask, Model:2626-7 (2022), 0 descendants of its own
- K220191: Disposable Face Mask (2022), 0 descendants of its own
- K211833: Disposable Medical  Face Mask (2022), 0 descendants of its own

## Indications for use
The Surgical 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 use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

Source page: https://510kreport.com/device/K202424
Methodology: https://510kreport.com/methodology