Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)— 510(k) K212293

Substantially Equivalent

Jiangmen Ningrui Medical Supplies Co., Ltd.

FDA 510(k) clearance K212293 for Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A), Substantially Equivalent on 2021-10-25. Applicant: Jiangmen Ningrui Medical Supplies Co., Ltd..

Clearance details

Applicant: Jiangmen Ningrui Medical Supplies Co., Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2021-07-22
Decision date: 2021-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taishan, 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.