Duns Number:526963345
Device Description: smooth surface, powder free
Catalog Number
-
Brand Name
Medical Nitrile Examination Gloves (Power free, Blue)
Version/Model Number
S
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
K210578,K210578,K210578,K210578
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
02b6fe80-7a90-4257-93f9-42d9745c6720
Public Version Date
September 08, 2021
Public Version Number
1
DI Record Publish Date
August 31, 2021
Package DI Number
26920756761964
Quantity per Package
10
Contains DI Package
16920756761967
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-