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 Glove, Tested For Use With Chemotherapy Drugs (blue).
| Device ID | K182600 |
| 510k Number | K182600 |
| Device Name: | Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs (Blue) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Better Care Plastic Technology Co., Ltd Fuqian Xi Road, West District Of Shenze Industrial Base, Shenze County Shenze County, CN 050000 |
| Contact | Zhu Chuyan |
| Correspondent | Kathy Liu Hongray USA Medical Products Inc 3973 Schaefer Avenue, Chino, CA 91810, USA Chino, CA 91810 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-21 |
| Decision Date | 2018-11-30 |
| Summary: | summary |