Duns Number:831375089
Device Description: PremierPro Powder Free Vinyl Exam Glove Standard Medium 100 count
Catalog Number
4043
Brand Name
PremierPro
Version/Model Number
4043
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
24d1dda8-c095-4721-b11c-67fd5d210fed
Public Version Date
July 02, 2020
Public Version Number
1
DI Record Publish Date
June 24, 2020
Package DI Number
10854344002513
Quantity per Package
10
Contains DI Package
00854344002516
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 |