Surgical Mask— 510(k) K212451

Substantially Equivalent

Remade USA, LLC

FDA 510(k) clearance K212451 for Surgical Mask, Substantially Equivalent on 2021-09-10. Applicant: Remade USA, LLC.

Clearance details

Applicant: Remade USA, LLC
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2021-08-05
Decision date: 2021-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, 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.