Duns Number:530438738
Device Description: Nitrile Medical Examination Gloves, powder-free, blue color, latex-free, ambidextrous, bea Nitrile Medical Examination Gloves, powder-free, blue color, latex-free, ambidextrous, beaded cuff, textured surface in the grip area, non-sterile.
Catalog Number
-
Brand Name
MocareHealth
Version/Model Number
723560
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
K030207,K030207
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
c00b2e3e-9549-498c-b65b-74b53878fab6
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
June 03, 2020
Package DI Number
36930518036817
Quantity per Package
10
Contains DI Package
06930518036816
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 | 6 |