Duns Number:831375089
Device Description: PremierPro Powder Free Vinyl Exam Glove Large 150count
Catalog Number
4034
Brand Name
PremierPro
Version/Model Number
4034
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
K100326,K100326
Product Code
LYZ
Product Code Name
Vinyl Patient Examination Glove
Public Device Record Key
ea591233-b0ad-4cc3-85cc-a984aac82fc9
Public Version Date
July 02, 2020
Public Version Number
1
DI Record Publish Date
June 24, 2020
Package DI Number
10818566012651
Quantity per Package
10
Contains DI Package
00818566012654
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 |