Duns Number:007941230
Device Description: Glove Exam XLarge NITRILE Blue For Use With Some Chemotherapy Drugs Not Made With Natural Glove Exam XLarge NITRILE Blue For Use With Some Chemotherapy Drugs Not Made With Natural Rubber Latex
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
GLV9304
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
K170136,K170136,K170136
Product Code
LZA
Product Code Name
Polymer patient examination glove
Public Device Record Key
4178555d-e868-402a-be89-3ddf2f4a8f66
Public Version Date
December 24, 2020
Public Version Number
1
DI Record Publish Date
December 16, 2020
Package DI Number
20885632295321
Quantity per Package
10
Contains DI Package
30885632295328
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 |