The following data is part of a premarket notification filed by Better Care Plastic Technology Co., Ltd. with the FDA for Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (dark Blue).
| Device ID | K222449 |
| 510k Number | K222449 |
| Device Name: | Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) |
| Classification | Patient Examination Glove, Specialty |
| 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 |
| Product Code | LZC |
| Subsequent Product Code | LZA |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-15 |
| Decision Date | 2022-08-27 |