Duns Number:012430880
Device Description: Criterion CR4G Chlor Glove Large
Catalog Number
1127309
Brand Name
Criterion CR4G Chlor Glove
Version/Model Number
1127309
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
LZA
Product Code Name
Polymer patient examination glove
Public Device Record Key
4efd3859-e333-41b7-a2a4-8ba1ecaa4f4a
Public Version Date
May 20, 2020
Public Version Number
1
DI Record Publish Date
May 12, 2020
Package DI Number
H65811273092
Quantity per Package
10
Contains DI Package
H65811273091
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 |