Duns Number:117257038
Device Description: BLUE, NITRILE MEDICAL EXAMINATION GLOVES, LATEX-FREE, POWDER-FREE, ASTM D6319
Catalog Number
-
Brand Name
J2-100
Version/Model Number
JVNGWZ4LC
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"
-
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
K192333,K192333
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
08548627-3a1e-4bfb-abc7-8e82b3ad6c8f
Public Version Date
June 14, 2021
Public Version Number
1
DI Record Publish Date
June 04, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 4 |