Duns Number:012430880
Device Description: Illusion Glove Strawberry Small
Catalog Number
1124992
Brand Name
Illusion Glove Strawberry
Version/Model Number
1124992
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
K093496,K093496,K093496
Product Code
LYY
Product Code Name
Latex patient examination glove
Public Device Record Key
eb210423-ef52-463e-a59b-2953c000a0c8
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
May 12, 2020
Package DI Number
H65811249922
Quantity per Package
20
Contains DI Package
H65811249921
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 |