510(k) K222480
K222480 is an FDA 510(k) premarket notification submitted by Foshan Nanhai Plus Medical Co, Ltd. for the device "Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)". The FDA issued a decision of Substantially Equivalent on November 14, 2022. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Foshan Nanhai Plus Medical Co, Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 14, 2022
- Date Received
- August 17, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gown, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type