Medical Surgical Mask (Model: JM92, JM92B)— 510(k) K220187

Substantially Equivalent

Guangdong Jia Mei Biological Technology Co.Ltd

FDA 510(k) clearance K220187 for Medical Surgical Mask (Model: JM92, JM92B), Substantially Equivalent on 2022-03-25. Applicant: Guangdong Jia Mei Biological Technology Co.Ltd.

Clearance details

Applicant: Guangdong Jia Mei Biological Technology Co.Ltd
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2022-01-24
Decision date: 2022-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiangmen, 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.