Medical surgical mask (Black mask, Level 1 and Level 3)— 510(k) K213450

Substantially Equivalent

Guangdong Kingfa Sci. & Tech.Co., Ltd.

FDA 510(k) clearance K213450 for Medical surgical mask (Black mask, Level 1 and Level 3), Substantially Equivalent on 2022-04-05. Applicant: Guangdong Kingfa Sci. & Tech.Co., Ltd..

Clearance details

Applicant: Guangdong Kingfa Sci. & Tech.Co., Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2021-10-26
Decision date: 2022-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Qingyuan City, 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.