The following data is part of a premarket notification filed by Suqian Linglian Medical Technology Co., Ltd with the FDA for Disposable Medical Nitrile Examination Gloves (non-sterile).
| Device ID | K212600 |
| 510k Number | K212600 |
| Device Name: | Disposable Medical Nitrile Examination Gloves (Non-sterile) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Suqian Linglian Medical Technology Co., Ltd No 1 Rd Wanpi Industrial Park, Xinshuguan Road, Shuyang County Suqian, CN 223699 |
| Contact | Eric Li |
| 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 | 2021-08-17 |
| Decision Date | 2021-11-18 |