Duns Number:012430880
Device Description: Criterion N250 PF Nitrile Glove SMALL
Catalog Number
5700100
Brand Name
Criterion N250 Nitrile PF Glove
Version/Model Number
5700100
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
LZA
Product Code Name
Polymer patient examination glove
Public Device Record Key
a949a916-31b0-4c78-8173-9868c734948f
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
January 03, 2020
Package DI Number
10304040077594
Quantity per Package
10
Contains DI Package
00304040077597
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 |