Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K200326 |
Device Name |
Powder Free Nitrile Examination Glove (Aqua Green) |
Applicant |
Riverstone Resources SDN BHD |
Lot 55, No 13 Jalan Jasmin 2 Kawasan Perindustrian |
Bukit Beruntung,
MY
48300
|
|
Applicant Contact |
Suresh Kumar |
Correspondent |
Riverstone Resources SDN BHD |
Lot 55, No 13 Jalan Jasmin 2 Kawasan Perindustrian |
Bukit Beruntung,
MY
48300
|
|
Correspondent Contact |
Suresh Kumar |
Regulation Number | 880.6250
|
Classification Product Code |
|
Date Received | 02/10/2020 |
Decision Date | 04/09/2020 |
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
|
|
|