Duns Number:080935429
Device Description: Nitrile Ambidextrous Gloves,X-Large, 8 mil
Catalog Number
CT5074G
Brand Name
ChemoPlus
Version/Model Number
CT5074G
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"
-
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
a558e96f-7b8c-48c6-a6f5-7142798d757d
Public Version Date
June 17, 2019
Public Version Number
3
DI Record Publish Date
June 30, 2018
Package DI Number
20884527021120
Quantity per Package
400
Contains DI Package
10884527021123
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 | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |