Duns Number:023904428
Device Description: Gloves, Nitrile Exam 3.0PF Textured Fingertips Cobalt Blue Extra Large
Catalog Number
-
Brand Name
McKesson
Version/Model Number
14-6N38EC
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)
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
623f7029-8115-44e6-9734-93dd1511cb3c
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
April 24, 2019
Package DI Number
00612479227644
Quantity per Package
10
Contains DI Package
00612479227637
Package Discontinue Date
-
Package Status
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 | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |