The following data is part of a premarket notification filed by Jiangsu Nanfang Medical Co., Ltd with the FDA for Disposable Medical Nitrile Examination Gloves (non Sterile).
| Device ID | K212639 |
| 510k Number | K212639 |
| Device Name: | Disposable Medical Nitrile Examination Gloves (Non Sterile) |
| Classification | Patient Examination Glove, Specialty |
| Applicant | Jiangsu Nanfang Medical Co., Ltd No. 1 Guoxiang Rd, Wujin Economic Development Zone, Wujin Changzhou, CN 213149 |
| Contact | Xia Li |
| Correspondent | Johnson Liu CNMED Consultant 31 Archer St Upper Mt Gravatt, AU 4122 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-20 |
| Decision Date | 2021-12-08 |