Duns Number:004072158
Device Description: SemperSure Green Nitrile Exam Glove, size XL
Catalog Number
SUNG205
Brand Name
SemperSure Green Nitrile Exam Glove
Version/Model Number
SUNG205
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K183441,K183441
Product Code
OPJ
Product Code Name
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
Public Device Record Key
a8f6e045-5b0b-4a47-89da-b55cc91af759
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
January 17, 2020
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 | 54 |