# K222335: Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Luoyang Sunmed Devices Co., Ltd.
- Decided: Oct 11, 2022 after 69 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: 7 generations back to K970835 (1997). 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)
- K202843: Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile), B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. (2021) Summary page 4.
- K212398: Surgical Face Mask (Non-sterile), Hubei Kimsoul Industrial Co., Ltd. (2021) Summary page 5.

## Indications for use
The product is intended to be worn to protect both the patients and healthcare personnel from transfer of microorganisms, body fluids and particulate materials. These masks are intended for adult use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile/sterile.

Source page: https://510kreport.com/device/K222335
Methodology: https://510kreport.com/methodology