Duns Number:012430880
Device Description: Criterion CL2 PF Latex Glove Large
Catalog Number
5701943
Brand Name
Criterion CL2
Version/Model Number
5701943
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
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
1e912ea2-50dd-4aa8-9938-dbf69d65d3bd
Public Version Date
June 24, 2020
Public Version Number
1
DI Record Publish Date
June 16, 2020
Package DI Number
20304040131644
Quantity per Package
10
Contains DI Package
10304040131647
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |