The following data is part of a premarket notification filed by Guangdong Zhong Ling Industrial Group Co., Ltd. with the FDA for Medical Disposable Face Mask Non Sterile.
| Device ID | K202650 |
| 510k Number | K202650 |
| Device Name: | Medical Disposable Face Mask Non Sterile |
| Classification | Mask, Surgical |
| Applicant | Guangdong Zhong Ling Industrial Group Co., Ltd. Room 101, Building 1, No. 5, Shengfeng Road Xinhe Wanjiang, Dongguan, CN 523045 |
| Contact | Ann Ho |
| Correspondent | Jinghua Zhou Guangzhou Junyi Information Technology Co., Ltd. Room 215, Huaming Building, Chebei Road Guangzhou, CN 511660 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-14 |
| Decision Date | 2021-03-24 |