The following data is part of a premarket notification filed by Jiangsu Bytech Medical Supplies Co.,ltd. with the FDA for Disposable Nitrile Examination Gloves (tested For Use With Chemotherapy Drugs) - Blue/black/purple.
| Device ID | K220382 |
| 510k Number | K220382 |
| Device Name: | Disposable Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) - Blue/Black/Purple |
| Classification | Polymer Patient Examination Glove |
| Applicant | Jiangsu Bytech Medical Supplies Co.,Ltd. NO.88 Junshi Road, Petroleum Equipment Industrial Park Jianyang Town, Jianhu County Yancheng City, CN 224700 |
| Contact | Shen Hongxing |
| 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 | 2022-02-10 |
| Decision Date | 2022-04-21 |