Duns Number:249008772
Device Description: The I-MED Nitrile Powder-free exam gloves. Durable nitrile material is incredibly soft whi The I-MED Nitrile Powder-free exam gloves. Durable nitrile material is incredibly soft while providing excellent chemical resistance as well as high virus protection. Enhanced tactile sensitivity allows for accurate work with smaller items.
Catalog Number
5000
Brand Name
I-MED Nitrile Powder-Free and Latex-Free Gloves
Version/Model Number
5000
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
QLA
Product Code Name
Decontamination systems for facemasks, surgical masks, face shields, and safety glasses
Public Device Record Key
ca365096-0f17-4dbb-b910-8879324beb7e
Public Version Date
October 05, 2022
Public Version Number
2
DI Record Publish Date
June 18, 2020
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 | 5 |