Duns Number:961027315
Device Description: AMBITEX GLV EXAM NON-STERILE NITRILE N400 BLUE POWDER-FREE EXTRA LARGE FINGERTIP TEXTURED AMBITEX GLV EXAM NON-STERILE NITRILE N400 BLUE POWDER-FREE EXTRA LARGE FINGERTIP TEXTURED STANDARD LENGTH 10/100
Catalog Number
NXL400
Brand Name
AMBITEX
Version/Model Number
NXL400
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
b60da766-d395-4327-bf06-78f96dbe0256
Public Version Date
September 03, 2020
Public Version Number
3
DI Record Publish Date
April 04, 2019
Package DI Number
10699320402259
Quantity per Package
10
Contains DI Package
00699320402252
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |