Device Classification Name |
Surgeon'S Gloves
|
510(k) Number |
K122557 |
Device Name |
MOTEX POWDER-FREE NITRILE SURGICAL GLOVES |
Applicant |
SHANGHAI MOTEX HEALTHCARE CO., LTD. |
NO. 369, JIASONG ZHONG ROAD |
HUAXIN, QINGPU |
SHANGHAI,
CN
201708
|
|
Applicant Contact |
JEN KE-MIN |
Correspondent |
SHANGHAI MOTEX HEALTHCARE CO., LTD. |
NO. 369, JIASONG ZHONG ROAD |
HUAXIN, QINGPU |
SHANGHAI,
CN
201708
|
|
Correspondent Contact |
JEN KE-MIN |
Regulation Number | 878.4460
|
Classification Product Code |
|
Date Received | 08/22/2012 |
Decision Date | 10/03/2013 |
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
|
|
|