American-Made Surgical Mask— 510(k) K210101

Substantially Equivalent

Armbrust, Inc.

FDA 510(k) clearance K210101 for American-Made Surgical Mask, Substantially Equivalent on 2022-01-26. Applicant: Armbrust, Inc..

Clearance details

Applicant: Armbrust, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2021-01-14
Decision date: 2022-01-26
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Pflugerville, TX, 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.