The following data is part of a premarket notification filed by Jiangsu Medplus Non-woven Manufacturer Co., Ltd. with the FDA for Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown.
| Device ID | K211422 |
| 510k Number | K211422 |
| Device Name: | Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown |
| Classification | Gown, Surgical |
| Applicant | Jiangsu Medplus Non-woven Manufacturer Co., Ltd. No.217 East Wencheng Road, Economic Development Zone Siyang, CN 223700 |
| Contact | Shuying An |
| 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 | 2021-05-07 |
| Decision Date | 2021-07-02 |