K231618 is an FDA 510(k) clearance for the 3 Layer Surgical Mask (134252531). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Original Mattress Factory, Inc. (Cleveland, US). The FDA issued a Cleared decision on July 28, 2023, 56 days after receiving the submission on June 2, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K231618 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2023 |
| Decision Date | July 28, 2023 |
| Days to Decision | 56 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 |