Single-Use Surgical Mask With Ear Loop— 510(k) K201691

Substantially Equivalent

Qiqihar Hengxin Medical Supplies, Ltd.

FDA 510(k) clearance K201691 for Single-Use Surgical Mask With Ear Loop, Substantially Equivalent on 2020-09-17. Applicant: Qiqihar Hengxin Medical Supplies, Ltd..

Clearance details

Applicant: Qiqihar Hengxin Medical Supplies, Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2020-06-22
Decision date: 2020-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Qiqihar, 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.