K153496 is an FDA 510(k) clearance for the Disposable Surgical Face Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Xiantao Rayxin Medical Products Co., Ltd. (Xiantao, CN). The FDA issued a Cleared decision on June 15, 2016, 191 days after receiving the submission on December 7, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K153496 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2015 |
| Decision Date | June 15, 2016 |
| Days to Decision | 191 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 |