510(k) K212357
K212357 is an FDA 510(k) premarket notification submitted by Wuhan Zonsen Medical Products Co., Ltd. for the device "Surgical isolation gown". The FDA issued a decision of Substantially Equivalent on January 20, 2022. The device falls under product code FYC (Gown, Isolation, Surgical), a Class II device regulated under 21 CFR 878.4040. Wuhan Zonsen Medical Products Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 20, 2022
- Date Received
- July 29, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gown, Isolation, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type