K221534 is an FDA 510(k) clearance for the Surgical Face Masks (Ear Loops And Tie-On). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by San-M Package Co., Ltd. (Shimada-City, JP). The FDA issued a Cleared decision on September 16, 2022, 112 days after receiving the submission on May 27, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K221534 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 27, 2022 |
| Decision Date | September 16, 2022 |
| Days to Decision | 112 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 |