Duns Number:006961700
Device Description: Powder-Free Nitrile Gloves - 50 Single Use Only Disposable Gloves, One Size Fits Most, Med Powder-Free Nitrile Gloves - 50 Single Use Only Disposable Gloves, One Size Fits Most, Medical Grade, Fits Either Hand, Barrier from Dirt & Germs, Non-Sterile
Catalog Number
-
Brand Name
Up & Up
Version/Model Number
245-07-0293
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
March 27, 2026
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
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
2ab0f4ef-e6dc-4ab7-8545-38e45a4cefa5
Public Version Date
July 20, 2022
Public Version Number
1
DI Record Publish Date
July 12, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 52 |
| U | Unclassified | 12 |