# K203078: CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW

- Pathway: 510(k) (Abbreviated)
- Applicant: Huizhou Tianchang Industrial Co., Ltd.
- Decided: Aug 19, 2022 after 675 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: 9 generations back to K874608 (1987). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202211: Disposable Medical Surgical Face Masks, Guangdong Kaidi Garments Co.,Ltd (2020). Cleared while this submission was under review Summary page 4.

## Indications for use
The CAREWE Surgical Face Masks Models N0OO1-AW, N002-AW, and N003-AW are intended to be worn to protect both the adult patient and healthcare personnel from transfer of microorganisms, body fluids and material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The masks are single-use and disposable.

Source page: https://510kreport.com/device/K203078
Methodology: https://510kreport.com/methodology