The following data is part of a premarket notification filed by Shanghai Jianzhong Medical Packaging Co., Ltd. with the FDA for Disposable Surgical Mask.
| Device ID | K202341 |
| 510k Number | K202341 |
| Device Name: | Disposable Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Shanghai Jianzhong Medical Packaging Co., Ltd. Bldg. 16, 789# Puxing Rd, Minhang District Shanghai, CN 201114 |
| Contact | Nina Huang |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O.BOX 120-119 Shanghai, CN 200120 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-17 |
| Decision Date | 2021-02-12 |