Device Classification Name |
Polymer Patient Examination Glove
|
510(k) Number |
K201531 |
Device Name |
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) |
Applicant |
Hartalega SDN. BHD. |
Dataran SD PJU9 |
Bandar Sri Damansara,
MY
52200
|
|
Applicant Contact |
Kuan Kam Hon |
Correspondent |
Hartalega SDN. BHD. |
NO. 7, Kawasan Perusahaan Suria |
Bestari Jaya,
MY
45600
|
|
Correspondent Contact |
Nurul Aisyah Kong |
Regulation Number | 880.6250
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/08/2020 |
Decision Date | 08/05/2020 |
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
|