Duns Number:068586441
Device Description: Glove Exam Latex N/S PF 5.5 Blue, 50/Bx
Catalog Number
787955
Brand Name
Dealmed
Version/Model Number
787955
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
-
Product Code
KGO
Product Code Name
Surgeon'S Gloves
Public Device Record Key
d9fdffed-ea03-4451-8011-cbf0bffbfcf3
Public Version Date
August 11, 2022
Public Version Number
1
DI Record Publish Date
August 03, 2022
Package DI Number
10817415022292
Quantity per Package
6
Contains DI Package
00817415022295
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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |