Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K131823 |
Device Name |
PROPRIETARY / DONGTAI/ OTHER CLIENTS PRIVATE LABELING |
Applicant |
DONG TAI CITY HUAYI GLOVES CO., LTD. |
RM 1606 BLDG, 1 JIAN XIANG YUAN NO. 209 |
BEI SI HUAN ZHONG RD HAI DI |
BEIJING,
CN
100083
|
|
Applicant Contact |
CHU XIAOAN |
Correspondent |
DONG TAI CITY HUAYI GLOVES CO., LTD. |
RM 1606 BLDG, 1 JIAN XIANG YUAN NO. 209 |
BEI SI HUAN ZHONG RD HAI DI |
BEIJING,
CN
100083
|
|
Correspondent Contact |
CHU XIAOAN |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 06/20/2013 |
Decision Date | 12/09/2013 |
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
|
|
|