Duns Number:111267330
Device Description: MICROFLEX USE-880 ULTRASENSE EC SIZE XXL (10.5-11.0), Nitrile Powder-Free Examination Glov MICROFLEX USE-880 ULTRASENSE EC SIZE XXL (10.5-11.0), Nitrile Powder-Free Examination Glove
Catalog Number
USE-880-XXL
Brand Name
MICROFLEX
Version/Model Number
USE-880-XXL
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
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
f3531f59-bcbe-4a05-a608-fe6254b81330
Public Version Date
March 22, 2022
Public Version Number
1
DI Record Publish Date
March 14, 2022
Package DI Number
00769799880193
Quantity per Package
10
Contains DI Package
00769799880292
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 |