Duns Number:985523874
Device Description: Nitrile Exam Glove Size: Small
Catalog Number
-
Brand Name
Amerisource Bergen
Version/Model Number
10014
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
dc2dc9f4-2e08-4ed9-acf6-e19d3d34ee11
Public Version Date
April 18, 2022
Public Version Number
2
DI Record Publish Date
November 18, 2021
Package DI Number
60368001100146
Quantity per Package
10
Contains DI Package
00368001100144
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |