Device Classification Name |
Latex Patient Examination Glove
|
510(k) Number |
K050529 |
Device Name |
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTER |
Applicant |
SPI GLOVES SDN. BHD. |
5, PERSIARAN GREENTOWN 8 |
GREENTOWN BUSINESS CENTER |
IPOH 30450,
MY
|
|
Applicant Contact |
CHOOI FONG CHUN |
Correspondent |
SPI GLOVES SDN. BHD. |
5, PERSIARAN GREENTOWN 8 |
GREENTOWN BUSINESS CENTER |
IPOH 30450,
MY
|
|
Correspondent Contact |
CHOOI FONG CHUN |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 03/02/2005 |
Decision Date | 03/16/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|