510(k) K210372— Disposable Surgical Mask

Substantially Equivalent

Dongguan Shin YI Healthcare Products Factory

Clearance details

Applicant: Dongguan Shin YI Healthcare Products Factory
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2021-02-08
Decision date: 2021-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dong Guan, 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.