Duns Number:063997360
Device Description: LDR GLOVE NITRILE EXAM 100 MD PWF
Catalog Number
5412168
Brand Name
LEADER
Version/Model Number
5412168
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
610233e5-802e-4305-b0ec-490c4dd637e5
Public Version Date
July 02, 2021
Public Version Number
3
DI Record Publish Date
September 23, 2018
Package DI Number
50096295133429
Quantity per Package
10
Contains DI Package
00096295133424
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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 39 |