SECURE-GARD SURGICAL AND PROCEDURE FACE MASK— 510(k) K140155

Substantially Equivalent

Cardinal Health200, LLC

FDA 510(k) clearance K140155 for SECURE-GARD SURGICAL AND PROCEDURE FACE MASK, Substantially Equivalent on 2014-06-20. Applicant: Cardinal Health200, LLC.

Clearance details

Applicant: Cardinal Health200, LLC
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2014-01-22
Decision date: 2014-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukegan, IL, US

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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.