Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K213440 |
Device Name |
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs |
Applicant |
Luliang Hongruida Health Protection Technology Co., Ltd. |
Zhaokua Area, Luliang Industrial Zone |
Qujing,
CN
655606
|
|
Applicant Contact |
Zhang Guocai |
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 Code |
|
Date Received | 10/25/2021 |
Decision Date | 02/18/2022 |
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
|
|
|