The following data is part of a premarket notification filed by Allmed Medical Products Co., Ltd with the FDA for Allmed Surgical Face Masks (ear Loops).
| Device ID | K202128 |
| 510k Number | K202128 |
| Device Name: | Allmed Surgical Face Masks (Ear Loops) |
| Classification | Mask, Surgical |
| Applicant | Allmed Medical Products Co., LTD No. 180 Gongyuan Road Majiadian Town Zhijiang, CN 443200 |
| Contact | Vince Tian |
| Correspondent | Vince Tian Allmed Medical Products Co., LTD No. 180 Gongyuan Road Majiadian Town Zhijiang, CN 443200 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-31 |
| Decision Date | 2021-06-03 |