K230395 is an FDA 510(k) clearance for the Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Durio Ppe Sdn Bhd (Johor Bahru, MY). The FDA issued a Cleared decision on July 17, 2023, 153 days after receiving the submission on February 14, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K230395 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2023 |
| Decision Date | July 17, 2023 |
| Days to Decision | 153 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 |