K232112 is an FDA 510(k) clearance for the R&G Surgical Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by R&G Seguridad E Higiene Industrial S.A.C. (Callao, PE). The FDA issued a Cleared decision on April 2, 2024, 263 days after receiving the submission on July 14, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K232112 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 2023 |
| Decision Date | April 02, 2024 |
| Days to Decision | 263 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 |