K211105 is an FDA 510(k) clearance for the Ear-Friendly Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Ray Co., Ltd. (Anyang-Si, KR). The FDA issued a Cleared decision on May 17, 2021, 34 days after receiving the submission on April 13, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K211105 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 2021 |
| Decision Date | May 17, 2021 |
| Days to Decision | 34 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 |