# K110027: Surgical Face Mask; Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Angeline Group, Ltd.
- Decided: Aug 5, 2011 after 212 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: 5 generations back to K874608 (1987). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051291: Non-Sterile Surgical Mask, A.R. Medicom, Inc. (2005) Summary page 1.

## Indications for use
The Surgical Face Mask, Type: Tie-on, Ear-loop is indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism and body fluid.

Source page: https://510kreport.com/device/K110027
Methodology: https://510kreport.com/methodology