Duns Number:007941230
Device Description: Glove Exam XLarge Nitrile Ice Blue For Use With Some Chemotherapy Drugs Not Made With Nat Glove Exam XLarge Nitrile Ice Blue For Use With Some Chemotherapy Drugs Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
GLV9404
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
4d77712e-f20e-4332-b7a4-883346756b63
Public Version Date
January 28, 2021
Public Version Number
1
DI Record Publish Date
January 20, 2021
Package DI Number
20885632341400
Quantity per Package
10
Contains DI Package
30885632341407
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 |