The following data is part of a premarket notification filed by Better Care Plastic Technology Co., Ltd. with the FDA for Powder Free Nitrile Examination Gloves (blue),tested For Use With Chemotherapy Drugs And Fentanyl Citrate.
| Device ID | K221269 |
| 510k Number | K221269 |
| Device Name: | Powder Free Nitrile Examination Gloves (Blue),Tested For Use With Chemotherapy Drugs And Fentanyl Citrate |
| Classification | Polymer Patient Examination Glove |
| Applicant | Better Care Plastic Technology Co., Ltd. Fuqian Xi Road, West District Of Shenze Industrial Base Shenze County, CN 050000 |
| Contact | Zhu Chunyan |
| Correspondent | Kathy Liu Hongray USA Medical Products Inc. 3973 Schaefer Avenue, Chino, CA 91710, USA Chino, CA 91710 |
| Product Code | LZA |
| Subsequent Product Code | LZC |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-02 |
| Decision Date | 2022-07-27 |