Duns Number:111267330
Device Description: MICRO-TOUCH Nitrile Sterile Single 425 313042 Size L, Nitrile Powder-Free Examination Glov MICRO-TOUCH Nitrile Sterile Single 425 313042 Size L, Nitrile Powder-Free Examination Glove
Catalog Number
6034253
Brand Name
MICRO-TOUCH
Version/Model Number
6034253
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
b30a3a73-d4c3-48cb-a411-c20f68d20e26
Public Version Date
April 04, 2022
Public Version Number
1
DI Record Publish Date
March 25, 2022
Package DI Number
H72660342532
Quantity per Package
10
Contains DI Package
H72660342531
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 | 36 |