Duns Number:054386458
Device Description: Get- A-Grip Nitrile Two-Toned Black/Green,Powder Free,Exam Grade Glove,Tested for use with Get- A-Grip Nitrile Two-Toned Black/Green,Powder Free,Exam Grade Glove,Tested for use with Fentanyl,Heroin and Gastric Acid Size M
Catalog Number
-
Brand Name
Get-A-Grip
Version/Model Number
79730PF-BKGR
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K220373,K220373,K220373,K220373
Product Code
LZA
Product Code Name
Polymer patient examination glove
Public Device Record Key
8965bde6-e6e1-4240-a652-24c0664b7875
Public Version Date
May 30, 2022
Public Version Number
1
DI Record Publish Date
May 20, 2022
Package DI Number
00150042054148
Quantity per Package
1000
Contains DI Package
00850042054147
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 12 |