Duns Number:023904428
Device Description: Latex Surgical Gloves / Powder Free / Chemo Tested, Sterile, Textured Size 7.5
Catalog Number
-
Brand Name
McKesson
Version/Model Number
14-31075
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
K183536,K183536,K183536
Product Code
KGO
Product Code Name
Surgeon'S Gloves
Public Device Record Key
f075f42a-87ca-4d2c-a50b-ad03767a722b
Public Version Date
October 20, 2021
Public Version Number
1
DI Record Publish Date
October 12, 2021
Package DI Number
00612479261334
Quantity per Package
50
Contains DI Package
00612479261327
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |