The following data is part of a premarket notification filed by Hantech Medical Device Co., Ltd. with the FDA for Disposable Medical Masks.
| Device ID | K221038 |
| 510k Number | K221038 |
| Device Name: | Disposable Medical Masks |
| Classification | Mask, Surgical |
| Applicant | Hantech Medical Device Co., Ltd. No 288, Sanheng Road Changhe Industridal Park, Cixi Ningbo, CN 315326 |
| Contact | Arnold Yang |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-04-07 |
| Decision Date | 2022-09-01 |