The following data is part of a premarket notification filed by Changzhou Universal Medical Equipment Co. Ltd. with the FDA for Nitrile Glove Powder Free Blue.
| Device ID | K210145 |
| 510k Number | K210145 |
| Device Name: | Nitrile Glove Powder Free Blue |
| Classification | Polymer Patient Examination Glove |
| Applicant | Changzhou Universal Medical Equipment CO. LTD. No 6 Xinxi Road Xinbei District, CN 213000 |
| Contact | Xiaohai Wan |
| Correspondent | Roxanne Dubois R. Dubois Consulting, LLC 1399 Robnick Ct. Campbell, CA 95008 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-21 |
| Decision Date | 2021-04-21 |