510(k) K212807— Surgical Masks

Substantially Equivalent

Weihai Hongyu Nonwoven Fabric Products Co., Ltd.

Clearance details

Applicant: Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2021-09-03
Decision date: 2021-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weihai, CN

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.