The following data is part of a premarket notification filed by Zhenjiang Huayang Latex Products Co., Ltd. with the FDA for Nitrile Examination Gloves.
| Device ID | K210106 |
| 510k Number | K210106 |
| Device Name: | Nitrile Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Zhenjiang Huayang Latex Products Co., Ltd. Lianhe Village, Xinba Town Yangzhong, CN 212212 |
| Contact | Han Sheng |
| 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 | 2021-01-15 |
| Decision Date | 2021-04-07 |