Duns Number:012430880
Device Description: Criterion CL Glove PF Latex Small
Catalog Number
1028296
Brand Name
Criterion CL Glove PF Latex
Version/Model Number
1028296
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)
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
K981917,K981917,K981917
Product Code
LYY
Product Code Name
Latex patient examination glove
Public Device Record Key
47b55430-1afd-4603-a873-f9aa440704f6
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
May 12, 2020
Package DI Number
H65810282962
Quantity per Package
10
Contains DI Package
H65810282961
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 |