Duns Number:530438738
Device Description: Nitrile Examination Gloves, Powder-free, Blue, Ambidextrous beaded cuff, Textured surface Nitrile Examination Gloves, Powder-free, Blue, Ambidextrous beaded cuff, Textured surface in the grip area, Non-sterile.
Catalog Number
-
Brand Name
MocareHealth
Version/Model Number
723575
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
K030207
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
c7f79ce5-7399-4c3b-86af-182df8d529ed
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
August 29, 2019
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 | 6 |