The following data is part of a premarket notification filed by Jiangxi Surefine Medical Co., Ltd. with the FDA for Blue Nitrile Exam Gloves.
| Device ID | K211341 |
| 510k Number | K211341 |
| Device Name: | Blue Nitrile Exam Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Jiangxi Surefine Medical Co., Ltd. Jinshan Rd., Yugan Hi-tech Industrial Park Shangrao, CN 335100 |
| Contact | Steve Zhu |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room608,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 | 2021-05-03 |
| Decision Date | 2021-07-29 |