Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K172867 |
Device Name |
Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange |
Applicant |
GMP MEDICARE SDN BHD (F25) |
LOT/PT64593, JLN Dahlia/KU8, KAW Perindustrian Meru Timur |
Klang,
MY
41050
|
|
Applicant Contact |
Noraini Raus |
Correspondent |
GMP MEDICARE SDN BHD (F25) |
LOT/PT64593, JLN Dahlia/KU8, KAW Perindustrian Meru Timur |
Klang,
MY
41050
|
|
Correspondent Contact |
Noraini Raus |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 09/20/2017 |
Decision Date | 05/10/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|