K202697 is an FDA 510(k) clearance for the United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by United Sewing Automation, Inc. (Mount Airy, US). The FDA issued a Cleared decision on May 13, 2021, 239 days after receiving the submission on September 16, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K202697 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2020 |
| Decision Date | May 13, 2021 |
| Days to Decision | 239 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 |