Duns Number:053618240
Device Description: Gloves,Orange,M,Exam,PR,PK100
Catalog Number
-
Brand Name
CONDOR
Version/Model Number
48UM70
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
4c028d56-51e0-4473-8c81-ac339147cd44
Public Version Date
April 08, 2022
Public Version Number
1
DI Record Publish Date
March 31, 2022
Package DI Number
20194484319964
Quantity per Package
10
Contains DI Package
10194484319967
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 1 |