510(k) K192290
K192290 is an FDA 510(k) premarket notification submitted by Xuchang Zhengde Environstar Medical Products Co., Ltd. for the device "50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown". The FDA issued a decision of Substantially Equivalent on Apr 30, 2020. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Xuchang Zhengde Environstar Medical Products Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 30, 2020
- Date Received
- Aug 23, 2019
- 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)