Medical Surgical Mask— 510(k) K222204

Substantially Equivalent

Guangzhou Zhengkang Medical Equipment Co.,Ltd

FDA 510(k) clearance K222204 for Medical Surgical Mask, Substantially Equivalent on 2022-09-23. Applicant: Guangzhou Zhengkang Medical Equipment Co.,Ltd.

Clearance details

Applicant
Guangzhou Zhengkang Medical Equipment Co.,Ltd
Product code
Code FXX
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Guangzhou, 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.