Duns Number:782209340
Device Description: Nitrile Biodegradable Powder Free Textured Blue Exam Gloves, Non- Sterile, Chemo and Fenta Nitrile Biodegradable Powder Free Textured Blue Exam Gloves, Non- Sterile, Chemo and Fentanyl Tested, size XL
Catalog Number
-
Brand Name
Uniseal BIO-NIT
Version/Model Number
422-9
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
516b02af-4e16-44c4-bc09-2e436afd8706
Public Version Date
August 30, 2022
Public Version Number
1
DI Record Publish Date
August 22, 2022
Package DI Number
30744514042293
Quantity per Package
10
Contains DI Package
20744514042296
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 | 1 |