Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K120970 |
Device Name |
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, COLORED (BLUE) |
Applicant |
TANGSHAN ZHONGHONG PULIN PLASTIC CO.,LTD |
RM 1606 BLDG 1 |
JIANXIANG YUAN NO.209 BEI SHI HUAN ZHO |
BEIJING,
CN
CH
|
|
Applicant Contact |
CHU XIAOAN |
Correspondent |
TANGSHAN ZHONGHONG PULIN PLASTIC CO.,LTD |
RM 1606 BLDG 1 |
JIANXIANG YUAN NO.209 BEI SHI HUAN ZHO |
BEIJING,
CN
CH
|
|
Correspondent Contact |
CHU XIAOAN |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 03/30/2012 |
Decision Date | 07/19/2012 |
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
|
|
|