Plain Surgical Mask— 510(k) K201517

Substantially Equivalent

Aok Tooling Limited

FDA 510(k) clearance K201517 for Plain Surgical Mask, Substantially Equivalent on 2020-09-04. Applicant: Aok Tooling Limited.

Clearance details

Applicant: Aok Tooling Limited
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2020-06-08
Decision date: 2020-09-04
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.