KNH Surgical Face Mask— 510(k) K203528

Substantially Equivalent

Knh Surgical Face Mask

FDA 510(k) clearance K203528 for KNH Surgical Face Mask, Substantially Equivalent on 2022-11-16. Applicant: Knh Surgical Face Mask.

Clearance details

Applicant: Knh Surgical Face Mask
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2020-12-02
Decision date: 2022-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tainan, TW

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.