# K201095: Sovereign America Surgical Face Mask

- Pathway: 510(k) (Abbreviated)
- Applicant: Homtex, Inc.
- Decided: Mar 19, 2021 after 329 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: 6 generations back to K970835 (1997). 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)
- K153409: Protect U Guard Earloop and Tie-On Mask (Blue, White or Green), Protect U Guard, LLC (2016) Summary page 4.

## Indications for use
Sovereign America Surgical Mask is intended for use by healthcare personnel to protect both patients and healthcare personnel against the transfer of microorganisms, bodily fluids and particulate material. This is a single use, disposable device, provided non-sterile.

Source page: https://510kreport.com/device/K201095
Methodology: https://510kreport.com/methodology