The following data is part of a premarket notification filed by Byd Auto Industry Company Limited with the FDA for Nitrile Gloves (model: Ne01).
| Device ID | K212840 |
| 510k Number | K212840 |
| Device Name: | Nitrile Gloves (Model: NE01) |
| Classification | Polymer Patient Examination Glove |
| Applicant | BYD Auto Industry Company Limited No.3001,3007, Pingshan Hengping Highway, Pingshan New District Shenzhen, CN 518119 |
| Contact | Liu Jiangling |
| Correspondent | Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, CN |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-07 |
| Decision Date | 2021-12-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16974528640073 | K212840 | 000 |
| 16974528640066 | K212840 | 000 |
| 16974528640059 | K212840 | 000 |
| 16974528640042 | K212840 | 000 |