Duns Number:068586441
Device Description: Glove Exam Nitrile N/S PF XLarge light Blue, 100/Bx
Catalog Number
787140
Brand Name
Dealmed
Version/Model Number
787140
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
K110981,K110981,K110981
Product Code
LZA
Product Code Name
Polymer patient examination glove
Public Device Record Key
34c3c161-9c4b-4011-aa62-11ea2fafc391
Public Version Date
August 11, 2022
Public Version Number
1
DI Record Publish Date
August 03, 2022
Package DI Number
10817415022575
Quantity per Package
10
Contains DI Package
00817415022578
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 |