Duns Number:176528040
Device Description: Polymer patient exam gloves
Catalog Number
7915
Brand Name
Green Guard Sani Safe Glove Dispenser
Version/Model Number
7915
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"
-
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
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
ed51e50f-1fb1-479b-80cd-1b1f28ace535
Public Version Date
July 04, 2019
Public Version Number
1
DI Record Publish Date
June 26, 2019
Package DI Number
50347682791556
Quantity per Package
24
Contains DI Package
00347682791551
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
master case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 36 |
2 | A medical device with a moderate to high risk that requires special controls. | 1 |
U | Unclassified | 1 |