SURGICAL FACE MASK— 510(k) K093901

Substantially Equivalent

Epard Protective Products, Ltd.

FDA 510(k) clearance K093901 for SURGICAL FACE MASK, Substantially Equivalent on 2010-09-10. Applicant: Epard Protective Products, Ltd..

Clearance details

Applicant: Epard Protective Products, Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2009-12-22
Decision date: 2010-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mosely, VA, 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.