The following data is part of a premarket notification filed by Anhui Fine Glove Medical Technology Co., Ltd with the FDA for Nitrile Examination Gloves.
| Device ID | K212551 |
| 510k Number | K212551 |
| Device Name: | Nitrile Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Anhui Fine Glove Medical Technology Co., Ltd Intersection Of Feng Xiang Avenue And GongYe Road Chuzhou, CN 233100 |
| Contact | Guanghao Liu |
| Correspondent | Johnson Liu CNMED Consultant 31 Archer St Upper Mt Gravatt, AU 4122 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-13 |
| Decision Date | 2021-11-05 |