K201182 is an FDA 510(k) clearance for the iMask Disposable Surgical Face Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Pac-Dent, Inc. (Brea, US). The FDA issued a Cleared decision on February 19, 2021, 294 days after receiving the submission on May 1, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K201182 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2020 |
| Decision Date | February 19, 2021 |
| Days to Decision | 294 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FXX - Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |