Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K223713 |
Device Name |
Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
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. |
3973 Schaefer Avenue |
Chino,
CA
91710
|
|
Correspondent Contact |
Kathy Liu |
Regulation Number | 880.6250
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/12/2022 |
Decision Date | 08/07/2023 |
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
|
|
|