Duns Number:018198668
Device Description: High Risk Nitrile Powder Free Medical Exam Gloves, 50/BX, Long Cuff, M
Catalog Number
-
Brand Name
Endurance
Version/Model Number
EDC902-BX
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
abb8efb8-2147-440a-92a8-3b4b3a2d0d17
Public Version Date
October 10, 2022
Public Version Number
1
DI Record Publish Date
October 01, 2022
Package DI Number
20857420007300
Quantity per Package
10
Contains DI Package
10857420007303
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 | 87 |