Device Classification Name |
Polymer Patient Examination Glove
|
510(k) Number |
K051662 |
Device Name |
VINYL NITRILE CO-POLYMER POWDER FREE EXAM GLOVES (BLUE COLOR) |
Applicant |
GRAND WORK PLASTIC PRODUCTS CO., LTD. |
DONGGAO INDUSTRIAL ZONE ZANHUANG |
ZANHUANG COUNTY,
CN
050000
|
|
Applicant Contact |
MICKY LIN |
Correspondent |
GRAND WORK PLASTIC PRODUCTS CO., LTD. |
3973 SCHAFER AVE. |
CHINO,
CA
91710
|
|
Correspondent Contact |
MICKY LIN |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 06/22/2005 |
Decision Date | 07/22/2005 |
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
|
|
|