Duns Number:831375089
Device Description: PremierPro Sterile Nitrile Exam Glove Pair Large
Catalog Number
5084
Brand Name
PremierPro
Version/Model Number
5084
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
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
2883a0cf-bf11-444f-9e4c-ddbbd64d158e
Public Version Date
July 06, 2020
Public Version Number
1
DI Record Publish Date
June 26, 2020
Package DI Number
00818566010490
Quantity per Package
50
Contains DI Package
00818566010452
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 486 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |
| U | Unclassified | 1 |