Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K183354 |
Device Name |
Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate |
Applicant |
GX Corporation SDN BHD |
LOT 6491, Batu 5 3/4, Sementa, Jalan Kapar |
Klang,
MY
42100
|
|
Applicant Contact |
Khon Pu Foo |
Correspondent |
GX Corporation SDN BHD |
LOT 6491, Batu 5 3/4, Sementa, Jalan Kapar |
Klang,
MY
42100
|
|
Correspondent Contact |
Foo Khon Pu |
Regulation Number | 880.6250
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/03/2018 |
Decision Date | 06/20/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|