Surgical Mask— 510(k) K203012

Substantially Equivalent

Customfab, Inc.

FDA 510(k) clearance K203012 for Surgical Mask, Substantially Equivalent on 2021-04-11. Applicant: Customfab, Inc..

Clearance details

Applicant: Customfab, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2020-10-01
Decision date: 2021-04-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Garden Grove, CA, US

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.