Duns Number:828690904
Device Description: Azur Nitrile Powder-Free, X-Large, Ultra-soft nitrile, Super stretchy for superior comfort Azur Nitrile Powder-Free, X-Large, Ultra-soft nitrile, Super stretchy for superior comfort, Packaging contains at least 80% recycled material, More gloves per box reduces packaging
Catalog Number
1061705
Brand Name
Azur
Version/Model Number
1061705
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
f2379dde-f65f-4956-9680-f9b42844fde7
Public Version Date
September 01, 2020
Public Version Number
1
DI Record Publish Date
August 24, 2020
Package DI Number
D79010617053
Quantity per Package
2000
Contains DI Package
D79010617051
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |