K210772 is an FDA 510(k) clearance for the 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Vr Vertical, LLC Dba Xrgo (Louisville, US). The FDA issued a Cleared decision on September 22, 2021, 191 days after receiving the submission on March 15, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K210772 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 2021 |
| Decision Date | September 22, 2021 |
| Days to Decision | 191 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 |