Device Classification Name |
latex patient examination glove
|
510(k) Number |
K011728 |
Device Name |
BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE, PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) ( |
Applicant |
BRIGHTWAY HOLDINGS SDN. BHD. |
LOT 1559, JALAN ISTIMEWA, |
BATU BELAH |
KLANG, SELANGOR,
MY
42100
|
|
Applicant Contact |
G. BASKARAN |
Correspondent |
BRIGHTWAY HOLDINGS SDN. BHD. |
LOT 1559, JALAN ISTIMEWA, |
BATU BELAH |
KLANG, SELANGOR,
MY
42100
|
|
Correspondent Contact |
G. BASKARAN |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 06/04/2001 |
Decision Date | 07/09/2001 |
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
|
|
|