Disposable Surgical Mask— 510(k) K202463

Substantially Equivalent

Unisources Group, LLC

FDA 510(k) clearance K202463 for Disposable Surgical Mask, Substantially Equivalent on 2020-09-18. Applicant: Unisources Group, LLC.

Clearance details

Applicant: Unisources Group, LLC
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2020-08-27
Decision date: 2020-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, 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.