Duns Number:961027315
Device Description: STERILE GLOVE 8 PACK
Catalog Number
17C2875A
Brand Name
CARDINAL HEALTH
Version/Model Number
17C2875A
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KGO
Product Code Name
Surgeon's gloves
Public Device Record Key
fdf0b4f4-4e37-4c3f-8661-cae26f390e1c
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
March 15, 2017
Package DI Number
50887488676881
Quantity per Package
13
Contains DI Package
10887488676883
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 |