Duns Number:671647476
Device Description: Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: MPack 10 inner Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: MPack 10 inner boxes/1 carton
Catalog Number
-
Brand Name
nitrylex classic+
Version/Model Number
RD30246903_0001
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
K172930
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
5cc69e18-d387-41d6-be35-1e7aa4eb2f75
Public Version Date
March 15, 2021
Public Version Number
1
DI Record Publish Date
March 05, 2021
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 | 20 |