Surgical Face Masks, Model: EFMDS-L50Pn BLU— 510(k) K230380

Substantially Equivalent

Iris USA

FDA 510(k) clearance K230380 for Surgical Face Masks, Model: EFMDS-L50Pn BLU, Substantially Equivalent on 2023-08-03. Applicant: Iris USA.

Clearance details

Applicant: Iris USA
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2023-02-13
Decision date: 2023-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasant Prairie, WI, 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.