Duns Number:021828553
Device Description: Disposable Nitrile Examination Gloves, Powder Free, 100/Box, Size X-Large
Catalog Number
3273/11
Brand Name
Majestic
Version/Model Number
3273/11
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
0c7451c4-b5a7-4ba1-9741-fc4c8fb10d38
Public Version Date
April 28, 2022
Public Version Number
1
DI Record Publish Date
April 20, 2022
Package DI Number
20731791034571
Quantity per Package
10
Contains DI Package
00731791034577
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE