Duns Number:080194935
Device Description: Essentials Powder free Ultra Nitrile Exam Gloves Size Small BOX/300
Catalog Number
-
Brand Name
Essentials by 3D Dental
Version/Model Number
NGU300-S
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
LZC
Product Code Name
Patient Examination Glove, Specialty
Public Device Record Key
4e814e67-317e-42ef-b19c-4a5b8be931d0
Public Version Date
May 21, 2021
Public Version Number
1
DI Record Publish Date
May 13, 2021
Package DI Number
00817169022718
Quantity per Package
10
Contains DI Package
00817169022695
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 142 |
| U | Unclassified | 1 |