Surgical Face Mask (Model: CM2006, CM2008, A88)— 510(k) K210878

Substantially Equivalent

Shenzhen Realtone Medical Appliance Co., Ltd.

FDA 510(k) clearance K210878 for Surgical Face Mask (Model: CM2006, CM2008, A88), Substantially Equivalent on 2021-09-28. Applicant: Shenzhen Realtone Medical Appliance Co., Ltd..

Clearance details

Applicant: Shenzhen Realtone Medical Appliance Co., Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2021-03-24
Decision date: 2021-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

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.