INTAI Surgical Mask (non-sterile)— 510(k) K210422

Substantially Equivalent

Intai Technology Corp.

FDA 510(k) clearance K210422 for INTAI Surgical Mask (non-sterile), Substantially Equivalent on 2022-03-30. Applicant: Intai Technology Corp..

Clearance details

Applicant: Intai Technology Corp.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2021-02-11
Decision date: 2022-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nantun Dist., 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.