Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield— 510(k) K210147

Substantially Equivalent

Unicoglobal, Inc.

FDA 510(k) clearance K210147 for Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield, Substantially Equivalent on 2021-12-22. Applicant: Unicoglobal, Inc..

Clearance details

Applicant: Unicoglobal, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2021-01-21
Decision date: 2021-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam, KR

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.