# K050689: Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: China Surgical Dressings Center Co., Ltd.
- Decided: Oct 26, 2005 after 223 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: 3 generations back to K874608 (1987). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940707: 3M Surgical Mask with Face Sheild, 3M Company (1994) Summary page 1.
- K012602: Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face Masks-Blue, Pink, White, Green. Crosstex, Crosstex Intl. (2002) Summary page 1.

## Indications for use
Surgical masks/Procedure Mask is a high 3 ply face mask is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patients and the operating room personnel from transfer of microorganisms, body fluids and particulate materials.

Source page: https://510kreport.com/device/K050689
Methodology: https://510kreport.com/methodology