Duns Number:080925610
Device Description: Nitrile Powder Free Examination Gloves Size Small
Catalog Number
-
Brand Name
Skintx
Version/Model Number
50005
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
1b1e8fe5-3894-4ecf-a3f7-6fbbfd3125d3
Public Version Date
October 07, 2022
Public Version Number
1
DI Record Publish Date
September 29, 2022
Package DI Number
B754500051
Quantity per Package
100
Contains DI Package
B75450005
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner