K202595 is an FDA 510(k) clearance for the Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Premier Guard USA, LLC (Jackson, US). The FDA issued a Cleared decision on January 21, 2021, 135 days after receiving the submission on September 8, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K202595 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2020 |
| Decision Date | January 21, 2021 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FXX - Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |