Duns Number:004072158
Device Description: SemperShield Nitrile Exam Glove, size XXL
Catalog Number
SSNF106
Brand Name
SemperShield Nitrile Exam Glove
Version/Model Number
SSNF106
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
-
Product Code
OPJ
Product Code Name
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
Public Device Record Key
176fda07-0ecf-4870-b16c-97cc210ae48a
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
January 01, 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 |