# Homtex, Inc.

- Location (FDA's records): Cullman, AL
- FDA decisions: 2 (2021–2021): 2 510(k) clearances
- Product codes: FXX (2)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- San-M Package Co., Ltd.: 1 (https://510kreport.com/company/san-m-package)
- Protect U Guard, LLC: 1 (https://510kreport.com/company/protect-u-guard)

## Recent decisions
- K211066: Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3 (Aug 19, 2021)
- K201095: Sovereign America Surgical Face Mask (Mar 19, 2021)

Source page: https://510kreport.com/company/homtex