Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K200019 |
Device Name |
Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black) |
Applicant |
Hartalega NGC Sdn. Bhd. |
Kawasan Perindustrian Tanjung |
Sepang,
MY
43900
|
|
Applicant Contact |
Kuan Mun Leong |
Correspondent |
Hartalega NGC Sdn. Bhd. |
Kawasan Perindustrian Tanjung |
Sepang,
MY
43900
|
|
Correspondent Contact |
Nurul Aisyah Kong |
Regulation Number | 880.6250
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/03/2020 |
Decision Date | 04/06/2020 |
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
|
|
|