Duns Number:081258380
Device Description: JMU Nitrile Examination Gloves, 3.3+/-0.3g, Size L, Powder-Free, Non-Sterile, Blue, 200pcs JMU Nitrile Examination Gloves, 3.3+/-0.3g, Size L, Powder-Free, Non-Sterile, Blue, 200pcs/box
Catalog Number
-
Brand Name
JMU
Version/Model Number
25301011
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K110981
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
88452351-8ec5-4563-8e5c-5a6da979f10b
Public Version Date
October 12, 2022
Public Version Number
1
DI Record Publish Date
October 04, 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 | 10 |