Duns Number:090125555
Device Description: NITRILE POWDER FREE EXAM GLOVES BLACK 6 MIL 10/100-MEDIUM
Catalog Number
GDNPF105M
Brand Name
Hand Armor
Version/Model Number
GDNPF105M
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"
-
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
69c22bc9-d70e-44e8-8104-b4c12daf3f25
Public Version Date
November 23, 2020
Public Version Number
3
DI Record Publish Date
April 20, 2020
Package DI Number
10787081126832
Quantity per Package
10
Contains DI Package
00787081126835
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box