Device Classification Name |
Polymer Patient Examination Glove
|
510(k) Number |
K220229 |
Device Name |
Powder Free Nitrile Examination Gloves, Orange |
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 |
Kathy Liu |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 01/27/2022 |
Decision Date | 03/26/2022 |
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
|
|
|