Duns Number:256880576
Device Description: Medicom AssureTouch Pure - Nitrile Medical Examination Gloves with Textured Fingertips - I Medicom AssureTouch Pure - Nitrile Medical Examination Gloves with Textured Fingertips - Indigo - Powder-Free - Large
Catalog Number
9970-D
Brand Name
Medicom AssureTouch
Version/Model Number
9970-D
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
K182383,K182383,K182383
Product Code
LZC
Product Code Name
Patient Examination Glove, Specialty
Public Device Record Key
b61f072d-0cef-47c7-a708-ce6f7a23bec3
Public Version Date
July 11, 2022
Public Version Number
5
DI Record Publish Date
January 16, 2019
Package DI Number
20686864059039
Quantity per Package
10
Contains DI Package
10686864059032
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 |