# K230569: Cardinal Health Surgical Mask With Anti-fog Hydrogel  (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel  (Level 1 )

- Pathway: 510(k) (Abbreviated)
- Applicant: Cardinalhealth
- Decided: Jul 3, 2023 after 124 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Cardinal HealthT Level 1 Surgical Mask with Anti-fog Hydrogel are intended to be worn by operating room personnel and other general healthcare workers to protect both the patients and the healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health TM Level 1 Surgical Mask with Anti-fog Hydrogel are single use, disposable devices provided non-sterile. Cardinal HealthT Level 3 Surgical Mask with Anti-fog Hydrogel are intended to be worn by operating room personnel and other general healthcare workers to protect both the patients and the healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates. The Cardinal Health TM Level 3 Surgical Mask with Anti-fog Hydrogel are single use, disposable devices provided non-sterile.

Source page: https://510kreport.com/device/K230569
Methodology: https://510kreport.com/methodology