510(k) K221838
K221838 is an FDA 510(k) premarket notification submitted by Shanghai Hua EN Industrial Co, Ltd. for the device "Surgical Face Mask (HNFM0103)". The FDA issued a decision of Substantially Equivalent on Aug 17, 2022. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Shanghai Hua EN Industrial Co, Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 17, 2022
- Date Received
- Jun 23, 2022
- 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
- 510(k)