Duns Number:023904428
Device Description: Nitrile Exam Gloves CHEMO TESTED 16" EXTENDED CUFF NON-STERILE size Large
Catalog Number
-
Brand Name
McKesson
Version/Model Number
14-6N166
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
K071119,K071119,K071119
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
640b5bdb-41db-4d8c-991a-4fc8a32a153b
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
April 22, 2019
Package DI Number
00612479241251
Quantity per Package
10
Contains DI Package
00612479241244
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 |