Protective Face Mask for Medical Use— 510(k) K202358

Substantially Equivalent

Hunan Heng Chang Pharmaceutical Co., Ltd.

FDA 510(k) clearance K202358 for Protective Face Mask for Medical Use, Substantially Equivalent on 2021-01-29. Applicant: Hunan Heng Chang Pharmaceutical Co., Ltd..

Clearance details

Applicant: Hunan Heng Chang Pharmaceutical Co., Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2020-08-19
Decision date: 2021-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changsha, 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.