Duns Number:023904428
Device Description: Exam Glove McKesson NonSterile Ivory Powder Free Stretch Vinyl Ambidextrous Smooth Not Che Exam Glove McKesson NonSterile Ivory Powder Free Stretch Vinyl Ambidextrous Smooth Not Chemo Approved X-Small
Catalog Number
-
Brand Name
McKesson
Version/Model Number
14-812
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
LYZ
Product Code Name
Vinyl Patient Examination Glove
Public Device Record Key
de29b04c-4b73-4a69-be34-097e90324bb6
Public Version Date
June 24, 2020
Public Version Number
1
DI Record Publish Date
June 16, 2020
Package DI Number
00612479150638
Quantity per Package
10
Contains DI Package
00612479150621
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 |