K232968 is an FDA 510(k) clearance for the Grande Medical Masks, Model SF-600. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Golden Grande Corp. (Tianan, TW). The FDA issued a Cleared decision on June 6, 2024, 259 days after receiving the submission on September 21, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K232968 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 2023 |
| Decision Date | June 06, 2024 |
| Days to Decision | 259 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 |