Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K230875 |
Device Name |
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims |
Applicant |
Central Medicare Sdn. Bhd. |
PT 2609-2620, Batu 8, Jalan Changkat Jong |
Teluk Intan,
MY
36000
|
|
Applicant Contact |
Chua Kah Ying |
Correspondent |
Central Medicare Sdn. Bhd. |
PT 2609-2620, Batu 8, Jalan Changkat Jong |
Teluk Intan,
MY
36000
|
|
Correspondent Contact |
Chua Kah Ying |
Regulation Number | 880.6250
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/30/2023 |
Decision Date | 07/20/2023 |
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
|
|
|