Grande Medical Masks, Model SF-600— 510(k) K232968

Substantially Equivalent

Golden Grande Corp.

FDA 510(k) clearance K232968 for Grande Medical Masks, Model SF-600, Substantially Equivalent on 2024-06-06. Applicant: Golden Grande Corp..

Clearance details

Applicant: Golden Grande Corp.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2023-09-21
Decision date: 2024-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tianan, 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.