Surgical Mask (Model: 0868F, 0866F)— 510(k) K221173

Substantially Equivalent

Jiangxi Sanhao Medical Instruments Co.,Ltd

FDA 510(k) clearance K221173 for Surgical Mask (Model: 0868F, 0866F), Substantially Equivalent on 2022-07-06. Applicant: Jiangxi Sanhao Medical Instruments Co.,Ltd.

Clearance details

Applicant: Jiangxi Sanhao Medical Instruments Co.,Ltd
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2022-04-25
Decision date: 2022-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ji'An, 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.