Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K180645 |
Device Name |
Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green) |
Applicant |
Hartalega Sdn Bhd |
C-G-9, Jalan Dataran Sd 1 |
Dataran Sd Pju 9 |
Bandar Sri Damansara,
MY
52200
|
|
Applicant Contact |
Mr. Kuan Kam Hon |
Correspondent |
Hartalega Sdn. Bhd. |
NO.7, Kawasan Perusahaan Suria |
Bestari Jaya,
MY
52200
|
|
Correspondent Contact |
Nural Aisyah Kong |
Regulation Number | 880.6250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/12/2018 |
Decision Date | 11/16/2018 |
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 |
Yes
|
|
|