Duns Number:111267330
Device Description: NOVAPLUS® GAMMEX® Non-Latex PI Underglove Size 8.5, Sterile Polyisoprene Powder-Free Surgi NOVAPLUS® GAMMEX® Non-Latex PI Underglove Size 8.5, Sterile Polyisoprene Powder-Free Surgical Glove
Catalog Number
V20687285
Brand Name
NOVAPLUS
Version/Model Number
V20687285
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"
Yes
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
KGO
Product Code Name
Surgeon'S Gloves
Public Device Record Key
552a7642-f638-49c8-9fd4-a47762d9a6be
Public Version Date
March 18, 2022
Public Version Number
1
DI Record Publish Date
March 10, 2022
Package DI Number
20014566600851
Quantity per Package
50
Contains DI Package
10014566600854
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Dispenser
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |