Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K152720 |
Device Name |
Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color |
Applicant |
XINGDA MEDICAL PRODUCTS CO., LTD. |
SOUTH OF SHENGZHUANG VILLAGE, LUANNAN COUNTY |
TANGSHAN,
CN
063502
|
|
Applicant Contact |
ZHANG LIXIA |
Correspondent |
XINGDA MEDICAL PRODUCTS CO.,LTD. |
ROOM 1606 BLDG. 1. JIANXIANG YUAN NO. 209 |
BEI SI HUAN ZHONG ROAD, HAIDIAN DIS |
BEIJING,
CN
100083
|
|
Correspondent Contact |
CHU XIAOAN |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 09/21/2015 |
Decision Date | 03/10/2016 |
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
|
|
|