Duns Number:111267330
Device Description: GAMMEX® PI Glove-in-Glove™ System Size 6.5, Sterile Powder-Free Surgical Glove, pre-donned GAMMEX® PI Glove-in-Glove™ System Size 6.5, Sterile Powder-Free Surgical Glove, pre-donned double gloving system of one polyisoprene (PI) surgical glove and one neoprene surgical glove
Catalog Number
340084065
Brand Name
GAMMEX
Version/Model Number
340084065
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
c4ca318a-5e42-42ee-8ee7-d33f387e160a
Public Version Date
February 24, 2022
Public Version Number
1
DI Record Publish Date
February 16, 2022
Package DI Number
25414566842650
Quantity per Package
50
Contains DI Package
15414566842653
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 |