K210513 is an FDA 510(k) clearance for the UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Universal Incorporation (Taipei City, TW). The FDA issued a Cleared decision on September 29, 2021, 218 days after receiving the submission on February 23, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K210513 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2021 |
| Decision Date | September 29, 2021 |
| Days to Decision | 218 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 |