Device Classification Name |
vinyl patient examination glove
|
510(k) Number |
K102152 |
Device Name |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
Applicant |
HEBEI TENGDA PLASTIC CO., LTD |
ROOM 1606 BLDG.1 JIANXIANG YUA |
NO.209 BEI SI HUAN ZHONG RD |
SHIJIAZHUANG,
CN
100083
|
|
Applicant Contact |
CHU XIAOAN |
Correspondent |
HEBEI TENGDA PLASTIC CO., LTD |
ROOM 1606 BLDG.1 JIANXIANG YUA |
NO.209 BEI SI HUAN ZHONG RD |
SHIJIAZHUANG,
CN
100083
|
|
Correspondent Contact |
CHU XIAOAN |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 07/30/2010 |
Decision Date | 04/28/2011 |
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
|
Recalls |
CDRH Recalls
|
|
|