The following data is part of a premarket notification filed by Blue Sail Medical Co., Ltd with the FDA for Powder Free Nitrile Examination Gloves (blue, White, Black, Violet Blue, Cobalt Blue).
| Device ID | K163126 |
| 510k Number | K163126 |
| Device Name: | Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt Blue) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Blue Sail Medical Co., Ltd No. 21 Qingtian Road Qilu Chemical Industrial Park Zibo, CN 255414 |
| Contact | Robin Liu |
| Correspondent | Robin Liu Blue Sail Medical Co., Ltd No. 21 Qingtian Road Qilu Chemical Industrial Park Zibo, CN 255414 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-08 |
| Decision Date | 2017-02-22 |