K171162 is an FDA 510(k) clearance for the Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Prestige Ameritech (North Richland Hills, US). The FDA issued a Cleared decision on August 15, 2017, 117 days after receiving the submission on April 20, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K171162 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 2017 |
| Decision Date | August 15, 2017 |
| Days to Decision | 117 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FXX - Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |