Duns Number:962708454
Device Description: Nitrile disposable 4 mil powder-free examination glove, 100 gloves per box. Medical Grade, Nitrile disposable 4 mil powder-free examination glove, 100 gloves per box. Medical Grade, Chemotherapy drug tested, Not made with Rubber Latex, Low Derma, Protection against Fentanyl, Single use, Non-sterile. Small Size.
Catalog Number
-
Brand Name
DEFENDER
Version/Model Number
AMSDEF4-S
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K181857,K181857
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
ad290b14-e9ec-4a3c-a876-7f323f33203f
Public Version Date
May 28, 2021
Public Version Number
1
DI Record Publish Date
May 20, 2021
Package DI Number
00850031575073
Quantity per Package
10
Contains DI Package
00850031575011
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 | 12 |