Duns Number:068586441
Device Description: Glove Exam Vinyl N/S PF Small Natural, 100/Bx
Catalog Number
787260
Brand Name
Dealmed
Version/Model Number
787260
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LYZ
Product Code Name
Vinyl patient examination glove
Public Device Record Key
444801b5-3975-44f3-ad3e-38e0573584a6
Public Version Date
April 28, 2021
Public Version Number
1
DI Record Publish Date
April 20, 2021
Package DI Number
10859140003436
Quantity per Package
10
Contains DI Package
00859140003439
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |