Device Classification Name |
surgeon's gloves
|
510(k) Number |
K013302 |
Device Name |
DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM |
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 | 878.4460
|
Classification Product Code |
|
Date Received | 10/03/2001 |
Decision Date | 12/17/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|