ClearMask Transparent Surgical Face Mask— 510(k) K200576

Substantially Equivalent

Clearmask, LLC

FDA 510(k) clearance K200576 for ClearMask Transparent Surgical Face Mask, Substantially Equivalent on 2020-04-06. Applicant: Clearmask, LLC.

Clearance details

Applicant: Clearmask, LLC
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2020-03-05
Decision date: 2020-04-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Baltimore, MD, 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.