Device Classification Name |
polymer patient examination glove
|
510(k) Number |
K180696 |
Device Name |
Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs) |
Applicant |
Medline Industries, Inc. |
Three Lakes Drive |
Northfield,
IL
60093
|
|
Applicant Contact |
Pauline Maralit |
Correspondent |
Medline Industries, Inc. |
Three Lakes Drive |
Northfield,
IL
60093
|
|
Correspondent Contact |
Pauline Maralit |
Regulation Number | 880.6250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/16/2018 |
Decision Date | 04/30/2018 |
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 |
Yes
|
|
|