The following data is part of a premarket notification filed by Better Care Plastic Technology Cp., Ltd with the FDA for Powder Free Nitrile Patient Examination Gloves, Blue.
| Device ID | K101595 |
| 510k Number | K101595 |
| Device Name: | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE |
| Classification | Polymer Patient Examination Glove |
| Applicant | BETTER CARE PLASTIC TECHNOLOGY CP., LTD 3973 SCHAEFER AVE Chino, CA 91710 |
| Contact | Jie Liu |
| Correspondent | Jie Liu BETTER CARE PLASTIC TECHNOLOGY CP., 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 | 2010-06-08 |
| Decision Date | 2010-08-06 |
| Summary: | summary |