Medical Surgical Mask— 510(k) K213724

Substantially Equivalent

Hunan Zhenheyikang Medical Instrument Co., Ltd.

FDA 510(k) clearance K213724 for Medical Surgical Mask, Substantially Equivalent on 2022-02-20. Applicant: Hunan Zhenheyikang Medical Instrument Co., Ltd..

Clearance details

Applicant: Hunan Zhenheyikang Medical Instrument Co., Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2021-11-26
Decision date: 2022-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xiangtan, 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.