Duns Number:021828553
Device Description: Disposable Nitrile Examination Gloves, Powder Free, 100/Box, Size Large
Catalog Number
3272/10
Brand Name
Majestic
Version/Model Number
3272/10
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
32e07fa7-45b9-488d-a6e1-f8247f19dbd2
Public Version Date
April 28, 2022
Public Version Number
1
DI Record Publish Date
April 20, 2022
Package DI Number
20731791138118
Quantity per Package
10
Contains DI Package
00731791138114
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE