K213001

Substantially Equivalent

Procedure Mask, Surgical Mask

Applicant: A Plus International, Inc.
Product code: FXX
Advisory panel: General, Plastic Surgery
Date received: 2021-09-20
Decision date: 2022-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chino, CA, US

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.