The following data is part of a premarket notification filed by Jiangsu Dihong Industry And Trade Co., Ltd. with the FDA for Nitrile Glove.
| Device ID | K211252 |
| 510k Number | K211252 |
| Device Name: | Nitrile Glove |
| Classification | Polymer Patient Examination Glove |
| Applicant | Jiangsu Dihong Industry And Trade Co., Ltd. Dongxiaodian Industrial Park Shuyang, CN 223616 |
| Contact | Sue Chen |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, CN 200120 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-26 |
| Decision Date | 2021-06-25 |