Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K121992 |
Device Name |
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR |
Applicant |
XINWEI (SHANDONG) PLASTIC AND RUBBER PRODUCTS CO., |
12390 EAST END AVE. |
CHINO,
CA
91710
|
|
Applicant Contact |
FRANK LIU |
Correspondent |
XINWEI (SHANDONG) PLASTIC AND RUBBER PRODUCTS CO., |
12390 EAST END AVE. |
CHINO,
CA
91710
|
|
Correspondent Contact |
FRANK LIU |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 07/06/2012 |
Decision Date | 10/16/2012 |
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
|
|
|