Duns Number:080593067
Device Description: Polyisoprene Surgical Gloves - Powder Free - Latex Free - Water-Soluble Protein Free - Siz Polyisoprene Surgical Gloves - Powder Free - Latex Free - Water-Soluble Protein Free - Size 7.0
Catalog Number
M716
Brand Name
MEDADV
Version/Model Number
M716
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K123126,K123126
Product Code
KGO
Product Code Name
Surgeon'S Gloves
Public Device Record Key
87458cd2-7c72-4e0c-b38b-94e47f5b40c2
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
March 01, 2018
Package DI Number
20819667020108
Quantity per Package
6
Contains DI Package
10819667020101
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 40 |