Duns Number:039612668
Device Description: Size Small
Catalog Number
-
Brand Name
Uline Black Exam Nitrile Gloves - Small
Version/Model Number
S-21081-S
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K092034,K092034,K092034
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
8a215599-d7e5-4cab-9ab6-fe6b6e98c4ec
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
January 13, 2020
Package DI Number
30851253007886
Quantity per Package
10
Contains DI Package
10851253007882
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 8 |
2 | A medical device with a moderate to high risk that requires special controls. | 1 |
U | Unclassified | 2 |