Device Classification Name |
latex patient examination glove
|
510(k) Number |
K020818 |
Device Name |
POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS |
Applicant |
ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD. MPWM-1E |
MCGAW PARK,
IL
60085
|
|
Applicant Contact |
ERICA SETHI |
Correspondent |
ALLEGIANCE HEALTHCARE CORP. |
1500 WAUKEGAN RD. MPWM-1E |
MCGAW PARK,
IL
60085
|
|
Correspondent Contact |
ERICA SETHI |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 03/13/2002 |
Decision Date | 07/05/2002 |
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
|