Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)— 510(k) K223068
Substantially EquivalentGuangdong 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.. Device class: 2.
Clearance details
- Applicant
- Guangdong Golden Leaves Technology Development Co., Ltd.
- Product code
- Code FXX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dongguan, CN
Recent devices under product code FXX
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Adverse events under product code FXX
product code FXX- Injury
- 137
- Total
- 137
Source: openFDA MAUDE database, through . 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.