K140155 is an FDA 510(k) clearance for the SECURE-GARD SURGICAL AND PROCEDURE FACE MASK. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on June 20, 2014, 149 days after receiving the submission on January 22, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K140155 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2014 |
| Decision Date | June 20, 2014 |
| Days to Decision | 149 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 |