The following data is part of a premarket notification filed by Impertech Industries Ltd. with the FDA for Impertech Surgical Face Mask.
| Device ID | K212046 |
| 510k Number | K212046 |
| Device Name: | Impertech Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Impertech Industries Ltd. 20 Derech Barkan St. Barkan, IL 4482000 |
| Contact | Mohamad Khweis |
| Correspondent | Vaibhav Arvind Rajal mdi Consultants Inc 55 Northern Blvd, Suite 200 Great Neck, NY 11021 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-30 |
| Decision Date | 2021-11-18 |