The following data is part of a premarket notification filed by Wuhan Huirui Technology Co., Ltd with the FDA for Nitrile Examination Gloves.
| Device ID | K212722 |
| 510k Number | K212722 |
| Device Name: | Nitrile Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Wuhan Huirui Technology Co., Ltd Building 29-1 And 29-2, Wuhan Dianjing School,Teyihao Community, Wangjiadian, Jiufeng Street, Jiufeng Township Wuhan, CN 430075 |
| Contact | Jing Li |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 Lujiazui East 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 | 2021-08-27 |
| Decision Date | 2021-11-26 |