K160269 is an FDA 510(k) clearance for the Surgical Face Masks (Ear loops and Tie-on). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by San-M Package Co., Ltd. (Shimada-City, JP). The FDA issued a Cleared decision on September 6, 2016, 217 days after receiving the submission on February 2, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K160269 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2016 |
| Decision Date | September 06, 2016 |
| Days to Decision | 217 days |
| Submission Type | Abbreviated |
| 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 |