Duns Number:112042723
Device Description: Adenna® Dark Light Disposable Nitrile Exam Gloves, Powder Free, Black, 9 mil, Medium, 100/ Adenna® Dark Light Disposable Nitrile Exam Gloves, Powder Free, Black, 9 mil, Medium, 100/bx, 10 bxs/cs
Catalog Number
DLG675
Brand Name
Dark Light
Version/Model Number
DLG675
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
020a677d-ce1d-4387-86cf-8208b75ad388
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
April 17, 2020
Package DI Number
10653195356758
Quantity per Package
10
Contains DI Package
00653195356751
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box