Duns Number:961027315
Device Description: Nitrile Exam Gloves Flexal w Dispensing Film
Catalog Number
88TNF03M
Brand Name
FLEXAL
Version/Model Number
88TNF03M
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2021
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
ce32ddff-95a5-478b-b63e-26b5b9e0bf21
Public Version Date
December 31, 2021
Public Version Number
5
DI Record Publish Date
September 22, 2018
Package DI Number
50885380140882
Quantity per Package
10
Contains DI Package
20885380140881
Package Discontinue Date
December 31, 2021
Package Status
Not 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 |