510(k) K230610
K230610 is an FDA 510(k) premarket notification submitted by Dongguan Shin YI Healthcare Products Factory for the device "Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)". The FDA issued a decision of Substantially Equivalent on Aug 23, 2023. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Dongguan Shin YI Healthcare Products Factory has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 23, 2023
- Date Received
- Mar 6, 2023
- 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)