Device Classification Name |
Surgeon'S Gloves
|
510(k) Number |
K000179 |
Device Name |
NUZONE NITRILE SURGICAL GLOVES POWDER FREE |
Applicant |
TERANG NUSA SDN BHD |
1 JALAN 8, PENGKALAN CHEPA 2 |
INDUSTRIAL ZONE, |
KOTA BHARU, KELANTAN,
MY
16100
|
|
Applicant Contact |
CHIN-GUAN LOW |
Correspondent |
TERANG NUSA SDN BHD |
1 JALAN 8, PENGKALAN CHEPA 2 |
INDUSTRIAL ZONE, |
KOTA BHARU, KELANTAN,
MY
16100
|
|
Correspondent Contact |
CHIN-GUAN LOW |
Regulation Number | 878.4460
|
Classification Product Code |
|
Date Received | 01/20/2000 |
Decision Date | 05/15/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|