The following data is part of a premarket notification filed by San-m Package Co., Ltd. with the FDA for Surgical Face Masks (ear Loops And Tie-on).
| Device ID | K221534 |
| 510k Number | K221534 |
| Device Name: | Surgical Face Masks (Ear Loops And Tie-On) |
| Classification | Mask, Surgical |
| Applicant | San-M Package Co., Ltd. 1086-1 Ojiro Shimada-city, JP 428-8652 |
| Contact | Akihiko Goto |
| Correspondent | Takahiro Haruyama Globizz Corporation 1411 W 190th St. Toyota Plaza #200 Gardena, CA 90248 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-27 |
| Decision Date | 2022-09-16 |