The following data is part of a premarket notification filed by Careplus (m) Sdn Bhd with the FDA for Powder Free Nitrile Examination Glove, Blue (colored)..
Device ID | K142862 |
510k Number | K142862 |
Device Name: | POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (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 | 2015-01-16 |
Summary: | summary |