Device Classification Name |
Surgeon'S Gloves
|
510(k) Number |
K113707 |
Device Name |
STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING |
Applicant |
CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES |
1430 WAUKEGAN RD. |
MCGAW PARK,
IL
60085
|
|
Applicant Contact |
TATYANA BOGDAN |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
NED DEVINE |
Regulation Number | 878.4460
|
Classification Product Code |
|
Date Received | 12/16/2011 |
Decision Date | 04/27/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|