Duns Number:831375089
Device Description: PremierPro Plus Improved Thinner Technology Nitrile Exam Glove Large 200count
Catalog Number
5064
Brand Name
PremierPro
Version/Model Number
5064
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)
-
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
1076629e-0be1-47b4-98a2-d78df37e3b5e
Public Version Date
August 27, 2020
Public Version Number
2
DI Record Publish Date
June 28, 2020
Package DI Number
10818566011036
Quantity per Package
10
Contains DI Package
00818566011039
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 | 486 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |
| U | Unclassified | 1 |