The following data is part of a premarket notification filed by Guangdong Goodfeeling Hygiene Material Tec Co., Ltd. with the FDA for Medical Surgical Mask (non-sterile).
| Device ID | K202761 |
| 510k Number | K202761 |
| Device Name: | Medical Surgical Mask (Non-sterile) |
| Classification | Mask, Surgical |
| Applicant | Guangdong GoodFeeling Hygiene Material Tec Co., Ltd. No.10 Phoenix Avenue Eco-industrial Park, Danzao Town, Nanhai Foshan, CN 528200 |
| Contact | Zheng Zhijin |
| Correspondent | Grace Liu Shenzhen Joyantech Consulting Co., Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, CN 518000 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-21 |
| Decision Date | 2021-04-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973078400130 | K202761 | 000 |