510(k) K202331
K202331 is an FDA 510(k) premarket notification submitted by Gemtier Medical (Shanghai), Inc. for the device "Medical Face Mask". The FDA issued a decision of Substantially Equivalent on February 2, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Gemtier Medical (Shanghai), Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 2, 2021
- Date Received
- August 17, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mask, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type