The following data is part of a premarket notification filed by Niujian Technology Co., Ltd with the FDA for Disposal Medical Nitrile Examination Gloves-tested For Use With Chemotherapy Drugs.
| Device ID | K220353 |
| 510k Number | K220353 |
| Device Name: | Disposal Medical Nitrile Examination Gloves-Tested For Use With Chemotherapy Drugs |
| Classification | Patient Examination Glove, Specialty |
| Applicant | Niujian Technology Co., Ltd Room 401, Building 1, Anfangcheng, No.919, East Qunxian Road Yuecheng District Shaoxing, CN 312030 |
| Contact | Alan Chow |
| Correspondent | Johnson Liu Cnmed Consulting 31 Archer St Upper Mount 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 | 2022-02-08 |
| Decision Date | 2022-03-31 |