Duns Number:961027315
Device Description: Cardinal Health™ XP Plus Powder-Free Latex Exam Gloves12” in Length Caution: This product Cardinal Health™ XP Plus Powder-Free Latex Exam Gloves12” in Length Caution: This product contains natural rubberlatex which may cause allergic reactions. Non-Sterile.
Catalog Number
L88HRL
Brand Name
CARDINAL HEALTH
Version/Model Number
L88HRL
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
b3e5a36a-bcb4-4366-ab0a-a8be5c771c48
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
September 25, 2018
Package DI Number
50885380070714
Quantity per Package
10
Contains DI Package
20885380070713
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 |