# K192374: Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health200, LLC
- Decided: Dec 2, 2019 after 94 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 K874608 (1987). 8 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140155: Secure-Gard Surgical and Procedure Face Mask, Cardinal Health200, LLC (2014) Summary page 4.

## Most influential descendants
- K211762: Altor Safety 4-Ply Surgical Mask (Model:62232) (2021), 1 descendant of its own
- K221209: PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops (2023), 0 descendants of its own
- K201732: Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On (2021), 0 descendants of its own

## Indications for use
The Cardinal Health™ Level 3 surgical masks with Anti-Fog Foam Strip are intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health™ Level 3 surgical masks are single use, disposable devices provided non-sterile.

Source page: https://510kreport.com/device/K192374
Methodology: https://510kreport.com/methodology