Device Classification Name |
Surgeon'S Gloves
|
510(k) Number |
K171898 |
Device Name |
Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs |
Applicant |
Better Care Plastic Technology Co., Ltd |
Fuqian Xi Road, West district of Shenze Industrial Base |
Shenze County,
CN
050000
|
|
Applicant Contact |
Zhu Chunyan |
Correspondent |
Hongray USA Medical Products Inc |
2235 E Francis St |
Ontario,
CA
91761
|
|
Correspondent Contact |
Kathy Liu |
Regulation Number | 878.4460
|
Classification Product Code |
|
Date Received | 06/26/2017 |
Decision Date | 08/18/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|