# K043199: Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Hong YA Non-Woven Products Co., Ltd.
- Decided: Feb 16, 2005 after 90 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: 2 generations back to K970835 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022256: Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green, Tucker & Associates (2004) Summary page 1.

## Indications for use
Surgical Face Mask is device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluids and particulate material.

Source page: https://510kreport.com/device/K043199
Methodology: https://510kreport.com/methodology