Duns Number:068586441
Device Description: Glove Exam Nitrile N/S PF X-Large Black, 100/Bx
Catalog Number
787354
Brand Name
Dealmed
Version/Model Number
787354
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)
Yes
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
903917c9-bf48-4c58-a6af-3e65b83e9da5
Public Version Date
October 02, 2020
Public Version Number
2
DI Record Publish Date
September 11, 2020
Package DI Number
10859140003856
Quantity per Package
10
Contains DI Package
00859140003859
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 |