# K203152: Disposable Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Chaozhou Cecilia Technology Co., Ltd.
- Decided: Aug 11, 2021 after 293 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
Disposable Face Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated for use in procedure or situation where there is a risk of exposure to microorganisms and body fluids.

Source page: https://510kreport.com/device/K203152
Methodology: https://510kreport.com/methodology