Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)
FDA 510(k) clearance K223068 · decided 2022-11-23
Clearance details
- K-number
- K223068
- Device name
- Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)
- Applicant
- Guangdong Golden Leaves Technology Development Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-09-30
- Decision date
- 2022-11-23
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- FXX
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Dongguan, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.