Medical Face Mask
FDA 510(k) clearance K202331 · decided 2021-02-02
Clearance details
- K-number
- K202331
- Device name
- Medical Face Mask
- Applicant
- Gemtier Medical (Shanghai), Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-08-17
- Decision date
- 2021-02-02
- Days to decision
- 169 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
- Shanghai, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.