K230395

Substantially Equivalent

Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)

Applicant: Durio Ppe Sdn Bhd
Product code: FXX
Advisory panel: General, Plastic Surgery
Date received: 2023-02-14
Decision date: 2023-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Johor Bahru, MY

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.