Device Classification Name |
Polymer Patient Examination Glove
|
510(k) Number |
K193666 |
Device Name |
Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff |
Applicant |
Medline Industries, Inc. |
Three Lakes Drive |
Northfield,
IL
60093
|
|
Applicant Contact |
Leontyne Banks |
Correspondent |
Medline Industries, Inc. |
Three Lakes Drive |
Northfield,
IL
60093
|
|
Correspondent Contact |
Leontyne Banks |
Regulation Number | 880.6250
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/31/2019 |
Decision Date | 08/04/2020 |
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
|