Device Classification Name |
vinyl patient examination glove
|
510(k) Number |
K100059 |
Device Name |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE) |
Applicant |
TANGSHAN ZHONGPU PLASTIC PRODUCTS CO., LTD |
ROOM 1606 BLDG 1, JIANXIANG |
YUAN NO. 209 BEI SI HUAN ZHO |
BEIJING,
CN
100083
|
|
Applicant Contact |
CHU XIAOAN |
Correspondent |
TANGSHAN ZHONGPU PLASTIC PRODUCTS CO., LTD |
ROOM 1606 BLDG 1, JIANXIANG |
YUAN NO. 209 BEI SI HUAN ZHO |
BEIJING,
CN
100083
|
|
Correspondent Contact |
CHU XIAOAN |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 01/08/2010 |
Decision Date | 07/01/2010 |
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
|
|
|