Comfort Guard Mask, level 1, Comfort Guard Mask, level 3— 510(k) K210860

Substantially Equivalent

Gri-Alleset, Inc.

FDA 510(k) clearance K210860 for Comfort Guard Mask, level 1, Comfort Guard Mask, level 3, Substantially Equivalent on 2022-04-07. Applicant: Gri-Alleset, Inc..

Clearance details

Applicant: Gri-Alleset, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2021-03-23
Decision date: 2022-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flowery Branch, GA, 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.