# K202457: M1 Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: CHISON Medical Technologies Co., Ltd.
- Decided: Apr 29, 2021 after 245 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
When properly worn, the surgical face mask is intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate material. This device is non sterile and for single use only.

Source page: https://510kreport.com/device/K202457
Methodology: https://510kreport.com/methodology