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 | K140816 |
| 510k Number | K140816 |
| 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. 3973 SCHAEFER AVE Chino, CA 91710 |
| Contact | Kathy Liu |
| Correspondent | Kathy Liu BETTER CARE PLASTIC TECHNOLOGY CO., LTD. 3973 SCHAEFER AVE Chino, CA 91710 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-01 |
| Decision Date | 2014-07-08 |
| Summary: | summary |