K142990 is an FDA 510(k) clearance for the Insta-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 March 4, 2015, 139 days after receiving the submission on October 16, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K142990 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 2014 |
| Decision Date | March 04, 2015 |
| Days to Decision | 139 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 |