Duns Number:961027315
Device Description: Latex Exam Gloves
Catalog Number
88LDM
Brand Name
CARDINAL HEALTH
Version/Model Number
88LDM
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
K101828,K101828,K101828
Product Code
LYY
Product Code Name
Latex patient examination glove
Public Device Record Key
0d1807af-fdcc-47b5-9bb2-db251d391e6e
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
June 10, 2020
Package DI Number
50885380174337
Quantity per Package
10
Contains DI Package
20885380174336
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 |