The following data is part of a premarket notification filed by Careplus (m) Sdn Bhd with the FDA for Nitrilecare Nitrile Examination Gloves Powder Free, Blue, Chemotest.
| Device ID | K162858 |
| 510k Number | K162858 |
| Device Name: | NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST |
| Classification | Patient Examination Glove, Specialty |
| Applicant | Careplus (M) SDN BHD Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate Seremban, MY 70450 |
| Contact | Lim Kwee Shyan |
| Correspondent | Lim Kwee Shyan Careplus (M) SDN BHD Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate Seremban, MY 70450 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-12 |
| Decision Date | 2017-07-24 |