Device Classification Name |
vinyl patient examination glove
|
510(k) Number |
K102569 |
Device Name |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) |
Applicant |
TANGSHAN KANGYUAN GLOVE CO., LTD. |
RM 1606 BLDG. 1. JIANXING YUAN |
NO. 209 BEI SI HUAN |
BEIJING,
CN
100083
|
|
Applicant Contact |
CHU XIAOAN |
Correspondent |
TANGSHAN KANGYUAN GLOVE CO., LTD. |
RM 1606 BLDG. 1. JIANXING YUAN |
NO. 209 BEI SI HUAN |
BEIJING,
CN
100083
|
|
Correspondent Contact |
CHU XIAOAN |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 09/07/2010 |
Decision Date | 10/21/2010 |
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
|
|
|