Duns Number:170199058
Device Description: Powder Free Nitrile Gloves, 50 single use only gloves (by weight), one size
Catalog Number
-
Brand Name
CareOne
Version/Model Number
041520125019
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 08, 2020
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
8dcaccdc-ffbe-4b88-861f-1b60aab4eb69
Public Version Date
August 19, 2021
Public Version Number
3
DI Record Publish Date
November 29, 2019
Package DI Number
10041520125016
Quantity per Package
24
Contains DI Package
00041520125019
Package Discontinue Date
May 08, 2020
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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |
| U | Unclassified | 2 |