Duns Number:080593067
Device Description: LATEX SURGICAL GLOVES - POWDER FREE 7.5
Catalog Number
M713
Brand Name
MEDADV
Version/Model Number
M713
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K063757,K063757
Product Code
KGO
Product Code Name
Surgeon'S Gloves
Public Device Record Key
0ed85ac6-d00b-40e9-a7e3-9233ebf55e47
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
March 01, 2018
Package DI Number
20819667020085
Quantity per Package
6
Contains DI Package
10819667020088
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 |