The following data is part of a premarket notification filed by Careplus (m) Sdn Bhd with the FDA for Powder Free Nitrile Examination Glove, White (colored).
| Device ID | K142858 |
| 510k Number | K142858 |
| Device Name: | POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Careplus (M) SDN BHD Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban Negeri Sembilan Darul Khusus, MY |
| Contact | Lim Kwee Shyan |
| Correspondent | Lim Kwee Shyan Careplus (M) SDN BHD Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban Negeri Sembilan Darul Khusus, MY |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-01 |
| Decision Date | 2015-02-09 |