Duns Number:256880576
Device Description: Medicom AssureTouch Power - Nitrile Medical Examination Gloves with Textured Fingertips - Medicom AssureTouch Power - Nitrile Medical Examination Gloves with Textured Fingertips - Extended Cuffs - Chemotherapy Tested - Powder-Free - Non-Sterile - Blue - Medium
Catalog Number
9999-C
Brand Name
Medicom AssureTouch
Version/Model Number
9999-C
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
K190454,K190454,K190454
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
0d4e1b56-0ae3-479b-9609-f0c7892358af
Public Version Date
October 06, 2022
Public Version Number
1
DI Record Publish Date
September 28, 2022
Package DI Number
20686864029131
Quantity per Package
10
Contains DI Package
10686864029134
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 2 |