Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K220672 |
Device Name |
Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim |
Applicant |
Riverstone Resources Sdn Bhd |
Lot 20852, No.119, Jalan Logam 7 |
Kamunting Raya Industrial Estate |
Taiping,
MY
34600
|
|
Applicant Contact |
Suresh Kumar |
Correspondent |
Riverstone Resources Sdn Bhd |
Lot 20852, No.119, Jalan Logam 7 |
Kamunting Raya Industrial Estate |
Taiping,
MY
34600
|
|
Correspondent Contact |
Suresh Kumar |
Regulation Number | 880.6250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/07/2022 |
Decision Date | 06/03/2022 |
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
|
|
|