The following data is part of a premarket notification filed by Jiujiang Taixin Technology Co., Ltd. with the FDA for Disposable Nitrile Examination Gloves (tested For Use With Chemotherapy Drugs).
| Device ID | K212919 |
| 510k Number | K212919 |
| Device Name: | Disposable Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Jiujiang Taixin Technology Co., Ltd. Zone A, Ruichang Science And Technology Park Ruichang City, CN 332200 |
| Contact | Li Xiaojie |
| 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 | 2021-09-14 |
| Decision Date | 2021-12-15 |