The following data is part of a premarket notification filed by Changzhou Dsb Medical Co., Ltd with the FDA for Disposable Procedural Ear-loop Face Mask.
| Device ID | K211042 |
| 510k Number | K211042 |
| Device Name: | Disposable Procedural Ear-loop Face Mask |
| Classification | Mask, Surgical |
| Applicant | Changzhou DSB Medical Co., LTD No. 98 Fumin Rd, Changzhou Economic Development Zone Changzhou, CN 213025 |
| Contact | Sunny Han |
| Correspondent | Mandy Wu Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Century Avenue Shanghai, CN 200122 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-08 |
| Decision Date | 2021-07-15 |