Surgical face mask— 510(k) K203704

Substantially Equivalent

Juntech(Jiaxing)Healthcare Materials Co,.Ltd

FDA 510(k) clearance K203704 for Surgical face mask, Substantially Equivalent on 2021-06-04. Applicant: Juntech(Jiaxing)Healthcare Materials Co,.Ltd.

Clearance details

Applicant: Juntech(Jiaxing)Healthcare Materials Co,.Ltd
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2020-12-18
Decision date: 2021-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiaxing, 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.