Duns Number:012430880
Device Description: Criterion Powder Free Surgical Gloves, Size 9.0
Catalog Number
5700642
Brand Name
Criterion Powder Free Surgical Gloves
Version/Model Number
5700642
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KGO
Product Code Name
Surgeon's gloves
Public Device Record Key
be5cb074-633b-4210-a5c1-91b297ee8a72
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
May 08, 2019
Package DI Number
10304040059040
Quantity per Package
4
Contains DI Package
00304040059043
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 |