510(k) K212812
K212812 is an FDA 510(k) premarket notification submitted by Xianning Marveldas Protective Articles Co., Ltd. for the device "Surgical Gown". The FDA issued a decision of Substantially Equivalent on Nov 16, 2022. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 16, 2022
- Date Received
- Sep 3, 2021
- 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
- 510(k)