Duns Number:111267330
Device Description: MICROFLEX EV-2050 EVOLUTION ONE SIZE XS (5.5-6.0), Latex Powder-Free Examination Glove
Catalog Number
EV-2050-XS
Brand Name
MICROFLEX
Version/Model Number
EV-2050-XS
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
LYY
Product Code Name
Latex Patient Examination Glove
Public Device Record Key
1ff80d17-797e-4f36-ac43-f73e354b52a7
Public Version Date
March 25, 2022
Public Version Number
1
DI Record Publish Date
March 17, 2022
Package DI Number
00769799205064
Quantity per Package
10
Contains DI Package
00769799205019
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 | 36 |