The following data is part of a premarket notification filed by Changzhou Universal Medical Equipment Co. Ltd with the FDA for Disposable Medical Nitrile Examination Gloves- Tested For Use With Chemotherapy Drugs.
| Device ID | K213910 |
| 510k Number | K213910 |
| Device Name: | Disposable Medical Nitrile Examination Gloves- Tested For Use With Chemotherapy Drugs |
| Classification | Patient Examination Glove, Specialty |
| Applicant | Changzhou Universal Medical Equipment Co. Ltd No. 6, Xinxi Road, Xinbei District Changzhou, CN 213000 |
| Contact | Cai Jin Fu |
| Correspondent | Cai Jin Fu Changzhou Universal Medical Equipment Co. Ltd No. 6, Xinxi Road, Xinbei District Changzhou, CN 213000 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-15 |
| Decision Date | 2022-03-10 |