Duns Number:080925610
Device Description: 6 Mil 12 Inches Black Nitrile Exam Powder Free Gloves - Large
Catalog Number
-
Brand Name
Care
Version/Model Number
CBK12-515
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
9b97e96f-7bfd-4f88-b22a-89b58526afab
Public Version Date
October 07, 2022
Public Version Number
1
DI Record Publish Date
September 29, 2022
Package DI Number
B754CBK125151
Quantity per Package
50
Contains DI Package
B754CBK12515
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner