Duns Number:080593067
Device Description: Nitrile Examination Gloves Powder Free Non-Sterile - 100 Units - Ambidextrous - Textured S Nitrile Examination Gloves Powder Free Non-Sterile - 100 Units - Ambidextrous - Textured Surface - Size Small
Catalog Number
M701
Brand Name
MEDADV
Version/Model Number
M701
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
K030207,K030207
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
4373aba9-9b3d-4a24-b9c8-56d3340e8862
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
March 01, 2018
Package DI Number
10819667020002
Quantity per Package
10
Contains DI Package
00819667020005
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 |