AOK 95A Medical Mask (20200049)— 510(k) K220876

Substantially Equivalent

Aok Tooling Limited

FDA 510(k) clearance K220876 for AOK 95A Medical Mask (20200049), Substantially Equivalent on 2022-07-27. Applicant: Aok Tooling Limited.

Clearance details

Applicant: Aok Tooling Limited
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2022-03-25
Decision date: 2022-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheung Sha Wan, Kowloon, 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.