# K203190: Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Rfx+Care Manufactoring Co., Ltd.
- Decided: Jun 2, 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: 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)
- K182515: Surgical Face Mask, Wuhan Dymex Healthcare Co., Ltd. (2019) Summary page 5.

## Indications for use
The surgical face mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided as sterile.

Source page: https://510kreport.com/device/K203190
Methodology: https://510kreport.com/methodology