Duns Number:671647476
Device Description: Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: XS Pack: 10 in Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: XS Pack: 10 inner boxes / carton
Catalog Number
-
Brand Name
nitrylex classic blue
Version/Model Number
RD30019901_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
ebde53b4-bd99-40f0-9af1-16a5231ee5cf
Public Version Date
February 17, 2021
Public Version Number
1
DI Record Publish Date
February 09, 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 |