Duns Number:611739033
Device Description: SUNNYCARE brand nitrile examination gloves powder free blue xxlarge size 100pcs/box 10box SUNNYCARE brand nitrile examination gloves powder free blue xxlarge size 100pcs/box 10boxes/case 5 mil chemo rated
Catalog Number
8605
Brand Name
sunnycare
Version/Model Number
8605
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
e6350561-e38f-4538-9a61-a6038f64b52d
Public Version Date
October 06, 2022
Public Version Number
1
DI Record Publish Date
September 28, 2022
Package DI Number
20850044355765
Quantity per Package
10
Contains DI Package
10850044355768
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 | 1 |