# K230617: Surgical Face Mask (L 175*95mm)

- Pathway: 510(k) (Traditional)
- Applicant: Henan Chaoya Medical Equipment Co., Ltd.
- Decided: Jun 1, 2023 after 87 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: 12 generations back to K874608 (1987). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221272: Medical Face Mask, Shandong Xingyu Gloves Co., Ltd. (2022) Summary page 5.

## Indications for use
The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use ininfection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

Source page: https://510kreport.com/device/K230617
Methodology: https://510kreport.com/methodology