Duns Number:659300918
Device Description: Nitrile Examination Gloves Powder Free, Blue Colored, Non-Sterile, Size: XS, QTY: 100 PCS Nitrile Examination Gloves Powder Free, Blue Colored, Non-Sterile, Size: XS, QTY: 100 PCS Gloves by weight, MADE IN MALAYSIA
Catalog Number
-
Brand Name
AG GLOVE
Version/Model Number
NB111
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
f532c7ac-dad6-4670-82bd-5beae0e79735
Public Version Date
August 09, 2022
Public Version Number
1
DI Record Publish Date
August 01, 2022
Package DI Number
00860008313515
Quantity per Package
10
Contains DI Package
00860008313508
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 | 4 |