Duns Number:078740398
Device Description: Nitrile Powder Free Medical Examination Gloves size 6-7 (S).
Catalog Number
-
Brand Name
Abena
Version/Model Number
290621
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 01, 2023
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"
-
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
fe1c0633-9d85-4f6b-8017-0781ac3162f9
Public Version Date
January 03, 2022
Public Version Number
4
DI Record Publish Date
March 21, 2020
Package DI Number
00850001271509
Quantity per Package
100
Contains DI Package
00850001271516
Package Discontinue Date
January 01, 2022
Package Status
Not 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 | 127 |