Device Classification Name |
Polymer Patient Examination Glove
|
510(k) Number |
K150340 |
Device Name |
POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue) |
Applicant |
HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD |
ESTERN INDUSTRIAL ZONE |
NANGONG CITY,
CN
051800
|
|
Applicant Contact |
Shaozhang Nan |
Correspondent |
Beijing Believe Tech. Service Co., Ltd. |
1-202, Build 3, Beijing New World, No.5 Chaoyang Rd., |
Chaoyang District |
Beijing,
CN
100024
|
|
Correspondent Contact |
Ray Wang |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 02/11/2015 |
Decision Date | 06/18/2015 |
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
|
|
|