The following data is part of a premarket notification filed by Shandong Blue Sail Health Technology Co., Ltd with the FDA for Powder Free Nitrile Examination Gloves, Blue And Violet Blue, Test For Use With Chemotherapy Drugs.
| Device ID | K220228 |
| 510k Number | K220228 |
| Device Name: | Powder Free Nitrile Examination Gloves, Blue And Violet Blue, Test For Use With Chemotherapy Drugs |
| Classification | Polymer Patient Examination Glove |
| Applicant | Shandong Blue Sail Health Technology Co., Ltd No. 1888 Langgao Road, Langshan Advanced Technology Industrial Park Weifang, CN 262600 |
| Contact | Shi Haifeng |
| Correspondent | Shi Haifeng Shandong Blue Sail Health Technology Co., Ltd No. 1888 Langgao Road, Langshan Advanced Technology Industrial Park Weifang, CN 262600 |
| Product Code | LZA |
| Subsequent Product Code | LZC |
| Subsequent Product Code | OPJ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-27 |
| Decision Date | 2022-03-18 |