Duns Number:961027315
Device Description: Flexam Powder-Free Nitrile Examination Gloves
Catalog Number
N8830NS
Brand Name
FLEXAM
Version/Model Number
N8830NS
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
bf2cb706-3cbe-4585-99a0-2417066e7c0c
Public Version Date
September 03, 2020
Public Version Number
3
DI Record Publish Date
June 14, 2019
Package DI Number
50885380035034
Quantity per Package
2
Contains DI Package
20885380035033
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |