Duns Number:080593067
Device Description: Latex Examination Gloves Powder Free Non-Sterile - 100 Units - Ambidextrous - Textured sur Latex Examination Gloves Powder Free Non-Sterile - 100 Units - Ambidextrous - Textured surface - Size Medium
Catalog Number
M705
Brand Name
MEDADV
Version/Model Number
M705
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
K020837,K020837
Product Code
LYY
Product Code Name
Latex Patient Examination Glove
Public Device Record Key
db0d545b-e054-4a66-8f4e-2f7622a894c3
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
January 09, 2018
Package DI Number
10819667020040
Quantity per Package
10
Contains DI Package
00819667020043
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 | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 40 |