The following data is part of a premarket notification filed by Xuchang Zhengde Environstar Medical Products Co., Ltd with the FDA for 50g Sms Standard Surgical Gown, 45g Sms Surgical Gown With Reinforcement, 68g Bvb Surgical Gown, 68g Bvb Splicing Surgical Gown.
| Device ID | K192290 |
| 510k Number | K192290 |
| Device Name: | 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown With Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown |
| Classification | Gown, Surgical |
| Applicant | Xuchang Zhengde Environstar Medical Products Co., Ltd NO.3 Weilai Road, Industry Cluster District, Yanling County Xuchang, CN 461200 |
| Contact | Johnny Johnny |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O Box 120-119 Shanghai, CN 200120 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-23 |
| Decision Date | 2020-04-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10326053117760 | K192290 | 000 |
| 10326053117753 | K192290 | 000 |