Duns Number:089569581
Device Description: PrimaPro GentleGuard Comfort Fit Nitrile Powder Free Examination Glove XX-Large, 180 Glove PrimaPro GentleGuard Comfort Fit Nitrile Powder Free Examination Glove XX-Large, 180 Gloves/Box, 10 Box/Case, 1,800 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use
Catalog Number
-
Brand Name
PrimaPro
Version/Model Number
225-45
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)
-
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
532e1f95-a21a-426b-9cf3-cc974aa7b0c0
Public Version Date
December 31, 2020
Public Version Number
2
DI Record Publish Date
September 09, 2020
Package DI Number
20850022371107
Quantity per Package
10
Contains DI Package
00850022371103
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case