Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K230779 |
Device Name |
Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
Applicant |
Shanxi Hongjin Plastic Technology Co., Ltd. |
Coal Bed Gas Industrial Zone, Qu'e Town, Daning County |
Linfen,
CN
042300
|
|
Applicant Contact |
Wu Zhigang |
Correspondent |
Hongray(USA) Medical Products Inc. |
3973 Schaefer Avenue |
Chino,
CA
91710
|
|
Correspondent Contact |
Liu Kathy |
Regulation Number | 880.6250
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/21/2023 |
Decision Date | 06/09/2023 |
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
|
|
|