Duns Number:080935429
Device Description: Latex Hand Specific Gloves,Large, 10 mil
Catalog Number
CT5057G
Brand Name
ChemoPlus
Version/Model Number
CT5057G
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
cf9fbe93-7b6e-4047-b1fe-50211f04d718
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
June 27, 2018
Package DI Number
20884521040776
Quantity per Package
400
Contains DI Package
10884521040779
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 |