The following data is part of a premarket notification filed by Jiangsu Jinlian Medical Technology Co., Ltd with the FDA for Nitrile Examination Glove (powder Free, Blue).
| Device ID | K212497 |
| 510k Number | K212497 |
| Device Name: | Nitrile Examination Glove (Powder Free, Blue) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Jiangsu Jinlian Medical Technology Co., Ltd No. 14 Factory Building, 1st Floor West Of Century Aveneul, Suqian Econo-Tech-Deve-Zone Suqian, CN 223800 |
| Contact | Wu Min |
| Correspondent | Ray Wang Beijin Believe-Med Technology Service Co., Ltd Rm.912, Building#15, XiYueHui, No.5, YiHe North Rd. FangShan District Beigin, CN 102401 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-09 |
| Decision Date | 2021-11-11 |