K202598 is an FDA 510(k) clearance for the 3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by 3A Medical Products Co., Ltd. (Liu An, CN). The FDA issued a Cleared decision on May 6, 2021, 240 days after receiving the submission on September 8, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K202598 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2020 |
| Decision Date | May 06, 2021 |
| Days to Decision | 240 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 |