Duns Number:961027315
Device Description: AMBITEX GLV EXAM NON-STERILE LATEX LXL200 CREAM POWDER-FREE EXTRA LARGE FULL TEXTURED STAN AMBITEX GLV EXAM NON-STERILE LATEX LXL200 CREAM POWDER-FREE EXTRA LARGE FULL TEXTURED STANDARD LENGTH 10/100
Catalog Number
LXL200
Brand Name
AMBITEX
Version/Model Number
LXL200
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
K051404,K093375,K051404,K093375,K051404,K093375
Product Code
LYY
Product Code Name
Latex patient examination glove
Public Device Record Key
e886d819-172e-4b0f-b037-62c1ee5b3303
Public Version Date
September 03, 2020
Public Version Number
3
DI Record Publish Date
February 18, 2019
Package DI Number
10699320102050
Quantity per Package
10
Contains DI Package
00699320102053
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 |