Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K121526 |
Device Name |
POWER-FREE NITRILE PATIENT EXAMINATION GLOVES |
Applicant |
SHANDONG JUNCHI MEDICAL PRODUCTS CO., LTD. |
12390 EAST END AVE. |
CHINO,
CA
91710
|
|
Applicant Contact |
CECILY SHENG |
Correspondent |
SHANDONG JUNCHI MEDICAL PRODUCTS CO., LTD. |
12390 EAST END AVE. |
CHINO,
CA
91710
|
|
Correspondent Contact |
CECILY SHENG |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 05/23/2012 |
Decision Date | 08/03/2012 |
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
|
|
|