# K220378: Sparta 3-Ply Surgical Disposable Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Sparta East, LLC
- Decided: Jun 30, 2022 after 140 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: 10 generations back to K874608 (1987). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202463: Disposable Surgical Mask, Unisources Group, LLC (2020) Summary page 5.
- K202096: 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On, Ecoguard, Inc. (2021) Summary page 7.

## Indications for use
The Sparta 3-Ply Surgical Disposable Face Mask is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The Sparta 3-Ply Surgical Disposable Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non-sterile, disposable device

Source page: https://510kreport.com/device/K220378
Methodology: https://510kreport.com/methodology