Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K182156 |
Device Name |
Powder-Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs |
Applicant |
Syntex Healthcare Products Co., Ltd |
No. 1, Fanjiazhuang, Industrial Zone, Xinji City, Hebei |
Province China 052360 |
Xinji City,
CN
052360
|
|
Applicant Contact |
Qiao Zhiqiang |
Correspondent |
Hongray USA Medical Products Inc |
3973 Schaefer Avenue, Chino, CA 91810, USA |
Chino,
CA
91810
|
|
Correspondent Contact |
Kathy Liu |
Regulation Number | 880.6250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/09/2018 |
Decision Date | 12/10/2018 |
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
|
|
|