Duns Number:828690904
Device Description: SuperNova Nitrile Powder-Free, Large, Revolutionary stretchy nitrile provides superior com SuperNova Nitrile Powder-Free, Large, Revolutionary stretchy nitrile provides superior comfort and increased tactile sensitivity, Textured fingertips, Packaging contains at least 70% recycled material, More gloves per box reduces packaging
Catalog Number
1061204
Brand Name
SuperNova
Version/Model Number
1061204
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
22d4ed4d-f870-48bf-a675-73bcd32a04c4
Public Version Date
September 01, 2020
Public Version Number
1
DI Record Publish Date
August 24, 2020
Package DI Number
D79010612043
Quantity per Package
2000
Contains DI Package
D79010612041
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 |