The following data is part of a premarket notification filed by Zibo Blue Sail Health Technology Co., Ltd with the FDA for Powder Free Nitrile Examination Gloves, (cobalt Blue And Violet Blue), Powder Free Latex Examination Gloves.
| Device ID | K221229 |
| 510k Number | K221229 |
| Device Name: | Powder Free Nitrile Examination Gloves, (Cobalt Blue And Violet Blue), Powder Free Latex Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Zibo Blue Sail Health Technology Co., Ltd No.1888 Honghua Road, High Technical Area Zibo, CN 255400 |
| Contact | Xu Shulong |
| Correspondent | Xu Shulong Zibo Blue Sail Health Technology Co., Ltd No.1888 Honghua Road, High Technical Area Zibo, CN 255400 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-29 |
| Decision Date | 2022-07-16 |