# K093901: Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Epard Protective Products, Ltd.
- Decided: Sep 10, 2010 after 262 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
This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.

Source page: https://510kreport.com/device/K093901
Methodology: https://510kreport.com/methodology