Duns Number:079147322
Device Description: SUPERB NITRILE POWDER FREE GLOVE X-LARGE 1/10/100
Catalog Number
-
Brand Name
OEM
Version/Model Number
GNF2034
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
c5ff9ab4-290e-4c3a-902a-f6646680443d
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
April 30, 2020
Package DI Number
00851685006661
Quantity per Package
10
Contains DI Package
10851685006668
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 | 89 |