Duns Number:830069063
Device Description: Nitrile Examination Gloves, 3.0 g, Chemo Rated, Latex-Free, Powder-Free, Non-Sterile, Larg Nitrile Examination Gloves, 3.0 g, Chemo Rated, Latex-Free, Powder-Free, Non-Sterile, Large, 100/box
Catalog Number
-
Brand Name
MH
Version/Model Number
60-365-LG
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)
-
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
1fc0309f-fdc1-4299-b031-6114112f9db2
Public Version Date
September 23, 2020
Public Version Number
1
DI Record Publish Date
September 15, 2020
Package DI Number
10850018327432
Quantity per Package
10
Contains DI Package
00850018327435
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 | 9 |