The following data is part of a premarket notification filed by Zibo Sinocare Plastic Products Co., Ltd with the FDA for Powder Free Nitrile Examination Gloves, Blue,test For Use With Chemotherapy Drugs.
| Device ID | K213306 |
| 510k Number | K213306 |
| Device Name: | Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy Drugs |
| Classification | Polymer Patient Examination Glove |
| Applicant | Zibo Sinocare Plastic Products Co., Ltd Lot 5, No. 21 Qingtian Road Zibo, CN 255414 |
| Contact | Mila Guo |
| Correspondent | Mila Guo Zibo Sinocare Plastic Products Co., Ltd Lot 5, No. 21 Qingtian Road 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 | 2021-10-04 |
| Decision Date | 2022-02-18 |