K133070 is an FDA 510(k) clearance for the SURGICAL FACE MASK (Ear Loops and Tie-on). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Bh Medical Products Co., Ltd. (Dover, US). The FDA issued a Cleared decision on June 22, 2015, 630 days after receiving the submission on September 30, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K133070 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2013 |
| Decision Date | June 22, 2015 |
| Days to Decision | 630 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 |