Duns Number:111267330
Device Description: GAMMEX® Non-Latex PI Ortho Size 6, Sterile Polyisoprene Powder-Free Surgical Glove
Catalog Number
20686560
Brand Name
GAMMEX
Version/Model Number
20686560
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
KGO
Product Code Name
Surgeon'S Gloves
Public Device Record Key
2a82a03a-62dc-48fa-96d2-8add3a609cf1
Public Version Date
February 18, 2022
Public Version Number
1
DI Record Publish Date
February 10, 2022
Package DI Number
20884792386511
Quantity per Package
50
Contains DI Package
00884792386517
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Dispenser
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |