The following data is part of a premarket notification filed by Changzhou Universal Medical Equipment Co. Ltd with the FDA for Disposable Medical Synthetic Nitrile Examination Gloves (non-sterile).
| Device ID | K211667 |
| 510k Number | K211667 |
| Device Name: | Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) |
| Classification | N-acetylprocainamide Control Materials |
| Applicant | Changzhou Universal Medical Equipment Co. Ltd No. 6, Xinxi Road, Xinbei District Changzhou, CN 213000 |
| Contact | Jerry Gao |
| Correspondent | Johnson Liu CNMED Consultant 31 Archer St Upper Mt Gravatt, AU 4122 |
| Product Code | LAZ |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-01 |
| Decision Date | 2021-09-23 |