Duns Number:611739033
Device Description: sunnycare brand nitrile examination gloves powder free size xlarge 100pcs/box; 10 boxes/ sunnycare brand nitrile examination gloves powder free size xlarge 100pcs/box; 10 boxes/case blue color powder free chemo rated
Catalog Number
-
Brand Name
sunnycare
Version/Model Number
8204
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
bb38ad27-ea0c-4735-8ca3-c49ea8d5a852
Public Version Date
October 07, 2022
Public Version Number
1
DI Record Publish Date
September 29, 2022
Package DI Number
20850044355673
Quantity per Package
100
Contains DI Package
10850044355676
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 |