K202650 is an FDA 510(k) clearance for the Medical disposable face mask non sterile. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Guangdong Zhong Ling Industrial Group Co., Ltd. (Xinhe Wanjiang, Dongguan, CN). The FDA issued a Cleared decision on March 24, 2021, 191 days after receiving the submission on September 14, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K202650 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 2020 |
| Decision Date | March 24, 2021 |
| 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 |