Duns Number:007941230
Device Description: Glove Exam Procedure Nitrile 9.5-Inch Cuff Medium Sterile Ambidextrous Singles Powder-Free Glove Exam Procedure Nitrile 9.5-Inch Cuff Medium Sterile Ambidextrous Singles Powder-Free Textured Beaded Cuff Disposable Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
GLV5002S
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)
-
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
3e1c645b-b0c3-41ab-869a-01d85ca8f8fc
Public Version Date
October 23, 2020
Public Version Number
1
DI Record Publish Date
October 15, 2020
Package DI Number
50885632111202
Quantity per Package
4
Contains DI Package
30885632111208
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |