The following data is part of a premarket notification filed by Jiangsu Dihong Industry And Trade Co., Ltd. with the FDA for Vinyl Glove.
| Device ID | K211904 |
| 510k Number | K211904 |
| Device Name: | Vinyl Glove |
| Classification | Vinyl 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 | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-21 |
| Decision Date | 2021-09-17 |