Device Classification Name |
Vinyl Patient Examination Glove
|
510(k) Number |
K082597 |
Device Name |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
Applicant |
TANGSHAN LINYUAN PLASTIC PRODUCTS CO., LTD |
ROOM 1606 BLDG. 1 JIANXIANG |
YUAN NO.209 BEI SI HUAN ZHC |
BEIJING,
CN
100083
|
|
Applicant Contact |
CHU XIAOAN |
Correspondent |
TANGSHAN LINYUAN PLASTIC PRODUCTS CO., LTD |
ROOM 1606 BLDG. 1 JIANXIANG |
YUAN NO.209 BEI SI HUAN ZHC |
BEIJING,
CN
100083
|
|
Correspondent Contact |
CHU XIAOAN |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 09/08/2008 |
Decision Date | 10/24/2008 |
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
|
|
|