Device Classification Name |
Latex Patient Examination Glove
|
510(k) Number |
K003350 |
Device Name |
HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE COATED (BLUE) |
Applicant |
PAMITEX INDUSTRIES SDN BHD |
BATU 2 1/2, JALAN RASAH |
SEREMBAN, N.S.,
MY
70300
|
|
Applicant Contact |
SAID AWANG |
Correspondent |
PAMITEX INDUSTRIES SDN BHD |
BATU 2 1/2, JALAN RASAH |
SEREMBAN, N.S.,
MY
70300
|
|
Correspondent Contact |
SAID AWANG |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 10/26/2000 |
Decision Date | 04/05/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|