The following data is part of a premarket notification filed by Changzhou Yihua Sanitation Material Co., Ltd with the FDA for Disposable Medical Nitrile Gloves.
| Device ID | K211673 |
| 510k Number | K211673 |
| Device Name: | Disposable Medical Nitrile Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Changzhou Yihua Sanitation Material Co., Ltd Sanhekou Village, Zhenglu Town, Tianning District Changzhou, CN 213000 |
| Contact | Ding Jie |
| Correspondent | Johnson Liu CNMED Consultant 31 Archer St Upper Mt Gravatt, AU 4122 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-01 |
| Decision Date | 2021-09-01 |