The following data is part of a premarket notification filed by Anhui Xinyisheng Medical Technology Co., Ltd with the FDA for Disposable Medical Nitrile Examination Gloves- Tested For Use With Chemotherapy Drugs.
| Device ID | K213325 |
| 510k Number | K213325 |
| Device Name: | Disposable Medical Nitrile Examination Gloves- Tested For Use With Chemotherapy Drugs |
| Classification | Patient Examination Glove, Specialty |
| Applicant | Anhui Xinyisheng Medical Technology Co., Ltd No.999 North Of The Intersection Of Tonghe Road And G343 Road Suzhou, CN 234300 |
| Contact | Wei Wei Tang |
| 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 | 2021-10-05 |
| Decision Date | 2022-01-28 |