Duns Number:111267330
Device Description: MICROFLEX US-220 ULTRASENSE SIZE L (8.5-9.0), Nitrile Powder-Free Examination Glove
Catalog Number
US-220-L
Brand Name
MICROFLEX
Version/Model Number
US-220-L
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
92e1b014-fe3f-4ad2-b4da-e26f4f4b38c0
Public Version Date
March 22, 2022
Public Version Number
1
DI Record Publish Date
March 14, 2022
Package DI Number
00769799220081
Quantity per Package
10
Contains DI Package
00769799220180
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 |