UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2— 510(k) K210513

Substantially Equivalent

Universal Incorporation

FDA 510(k) clearance K210513 for UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2, Substantially Equivalent on 2021-09-29. Applicant: Universal Incorporation.

Clearance details

Applicant: Universal Incorporation
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2021-02-23
Decision date: 2021-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, TW

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.