Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K142862 |
Device Name |
POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). |
Applicant |
Careplus (M) SDN BHD |
Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate, |
70450 Seremban |
Negeri Sembilan Darul Khusus,
MY
|
|
Applicant Contact |
Lim Kwee Shyan |
Correspondent |
Careplus (M) SDN BHD |
Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate, |
70450 Seremban |
Negeri Sembilan Darul Khusus,
MY
|
|
Correspondent Contact |
Lim Kwee Shyan |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 10/01/2014 |
Decision Date | 01/16/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|