Duns Number:111267330
Device Description: CABVI PF Cobalt Nitrile 72-1050xR SIZE XS, Nitrile Powder-Free Examination Glove
Catalog Number
72-10500R
Brand Name
CABVI/High Five
Version/Model Number
72-10500R
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
338fc0c7-7cda-432a-bd77-f323ccd9bb76
Public Version Date
April 22, 2022
Public Version Number
1
DI Record Publish Date
April 14, 2022
Package DI Number
10071503216813
Quantity per Package
10
Contains DI Package
00071503216816
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |