Device Classification Name |
Latex Patient Examination Glove
|
510(k) Number |
K003132 |
Device Name |
DERMAGRIP POWDER FREE BLUE POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAM OR LESS OF TOTAL WA |
Applicant |
WRP SPECIALTY PRODUCTS SDN. BHD. |
LOT11, JL.2,KAWASAN PERUSAHAAN |
BANDAR BARU SLAK TINGGI |
SELANGOR DAURL EHSAN, SEPANG,
MY
43900
|
|
Applicant Contact |
MOHD HAIZAN HUSSEIN |
Correspondent |
WRP SPECIALTY PRODUCTS SDN. BHD. |
LOT11, JL.2,KAWASAN PERUSAHAAN |
BANDAR BARU SLAK TINGGI |
SELANGOR DAURL EHSAN, SEPANG,
MY
43900
|
|
Correspondent Contact |
MOHD HAIZAN HUSSEIN |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 10/06/2000 |
Decision Date | 11/17/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|