The following data is part of a premarket notification filed by Jiangsu Newvalue Medical Products Co., Ltd. with the FDA for Disposable Surgical Face Mask.
| Device ID | K202491 |
| 510k Number | K202491 |
| Device Name: | Disposable Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Jiangsu NewValue Medical Products Co., Ltd. Building G35, No. I Avenue, China Medical City Taizhou, CN 225300 |
| Contact | Zhou Zhengguo |
| Correspondent | Julie Chen Shanghai Medical Business Consulting Co., Ltd. Room 304, No 170 Huajiang Road, Jiading District Shanghai, CN 201803 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-31 |
| Decision Date | 2021-01-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970206822550 | K202491 | 000 |
| 06970206825179 | K202491 | 000 |
| 06970206825155 | K202491 | 000 |