Device Classification Name |
medical glove, specialty
|
510(k) Number |
K193555 |
Device Name |
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate |
Applicant |
Ever Global (Vietnam) Enterprise Corp |
Long Thanh Industrial Zone |
Taman Village |
Dong Nai Province,
VN
810000
|
|
Applicant Contact |
Jerry Lin |
Correspondent |
Elizabeth Deng |
5748 Eaglewood Place |
Ranch Cucamonga,
CA
91730
|
|
Correspondent Contact |
Elizabeth Deng |
Regulation Number | 880.6250
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/20/2019 |
Decision Date | 06/04/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|