Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )— 510(k) K230569

Substantially Equivalent

Cardinalhealth

FDA 510(k) clearance K230569 for Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 ), Substantially Equivalent on 2023-07-03. Applicant: Cardinalhealth.

Clearance details

Applicant: Cardinalhealth
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2023-03-01
Decision date: 2023-07-03
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Waukegan, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.