Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)— 510(k) K223068

Substantially Equivalent

Guangdong Golden Leaves Technology Development Co., Ltd.

FDA 510(k) clearance K223068 for Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E), Substantially Equivalent on 2022-11-23. Applicant: Guangdong Golden Leaves Technology Development Co., Ltd..

Clearance details

Applicant: Guangdong Golden Leaves Technology Development Co., Ltd.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2022-09-30
Decision date: 2022-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dongguan, 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.