D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply— 510(k) K213970

Substantially Equivalent

Danameco Medical Joint Stock Corporation

FDA 510(k) clearance K213970 for D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply, Substantially Equivalent on 2022-01-23. Applicant: Danameco Medical Joint Stock Corporation.

Clearance details

Applicant: Danameco Medical Joint Stock Corporation
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2021-12-20
Decision date: 2022-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Da Nang, VN

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.