Duns Number:256880576
Device Description: Medicom AssureTouch Ultra Tough - Fully Textured - Nitrile Medical Examination Gloves - Po Medicom AssureTouch Ultra Tough - Fully Textured - Nitrile Medical Examination Gloves - Powder Free - Non-Sterile - Black - Sample 3 Pairs
Catalog Number
9950-SP6
Brand Name
Medicom AssureTouch
Version/Model Number
9950-SP6
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
K143247,K143247
Product Code
LZA
Product Code Name
Polymer patient examination glove
Public Device Record Key
7bf61dd4-ada0-4493-a549-11439474fb5d
Public Version Date
October 06, 2022
Public Version Number
1
DI Record Publish Date
September 28, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |