The following data is part of a premarket notification filed by Guangdong Golden Leaves Technology Development Co., Ltd with the FDA for Medical Protective Mask (model: 8862, 8862a, 8862b, 8862c, 8862d, 8862e).
| Device ID | K223068 |
| 510k Number | K223068 |
| Device Name: | Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) |
| Classification | Mask, Surgical |
| Applicant | Guangdong Golden Leaves Technology Development Co., LTD 5/F, Building 2, No. 8, Qiaolonghe East Road Tangxia Town Dongguan, CN 523730 |
| Contact | Wenhong Zhou |
| Correspondent | Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District Guangzhou, CN 523000 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-30 |
| Decision Date | 2022-11-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973125150889 | K223068 | 000 |
| 06973125150865 | K223068 | 000 |
| 06973125150902 | K223068 | 000 |
| 06973125150896 | K223068 | 000 |
| 06973125150872 | K223068 | 000 |
| 06973125150858 | K223068 | 000 |