The following data is part of a premarket notification filed by Zibo Chengxun Automatic Device Co., Ltd with the FDA for Powder Free Nitrile Examination Gloves (white, Cobalt Blue, Black, Blue And Violet Blue).
| Device ID | K170393 |
| 510k Number | K170393 |
| Device Name: | Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue And Violet Blue) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Zibo Chengxun Automatic Device Co., Ltd No. 37 Minan Road, High-tech Industrial Park Zibo, CN 255088 |
| Contact | Ding Wei |
| Correspondent | Ding Wei Zibo Chengxun Automatic Device Co., Ltd No. 37 Minan Road, High-tech Industrial Park Zibo, CN 255088 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-08 |
| Decision Date | 2017-05-09 |