The following data is part of a premarket notification filed by Yangzhou Runyi Arts & Crafts Co., Ltd. with the FDA for Disposable Medical Mask.
| Device ID | K203112 |
| 510k Number | K203112 |
| Device Name: | Disposable Medical Mask |
| Classification | Mask, Surgical |
| Applicant | Yangzhou Runyi Arts & Crafts CO., LTD. 4. NO.87 West Heye Road HanJiang District Yangzhou, CN 225008 |
| Contact | Li Yu |
| Correspondent | Helen Nan Wenzhou Cytech Information Service Co., Ltd. Room302, Building3, Hangqian Mansion, Hangqian Street, Lucheng District Wenzhou, CN 32500 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-15 |
| Decision Date | 2021-09-16 |