Medical mask (Model: KKF-1A)— 510(k) K202316

Substantially Equivalent

Han Zhaoqing Sporting Goods Company Limited

FDA 510(k) clearance K202316 for Medical mask (Model: KKF-1A), Substantially Equivalent on 2021-03-03. Applicant: Han Zhaoqing Sporting Goods Company Limited.

Clearance details

Applicant
Han Zhaoqing Sporting Goods Company Limited
Product code
Code FXX
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Zhaoqing, CN
Download summary PDFView on FDA.gov ↗

Adverse events under product code FXX

product code FXX
Injury
137
Total
137

Source: openFDA MAUDE database, through . 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.