Surgical Face Mask (HNFM0304)— 510(k) K221222

Substantially Equivalent

Shanghai Hua EN Industrial Co, Ltd.

FDA 510(k) clearance K221222 for Surgical Face Mask (HNFM0304), Substantially Equivalent on 2022-06-06. Applicant: Shanghai Hua EN Industrial Co, Ltd..

Clearance details

Applicant: Shanghai Hua EN Industrial Co, Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2022-04-27
Decision date: 2022-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

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.