Duns Number:004072158
Device Description: SemperCare Stretch Vinyl Walleted Exam Glove, size L
Catalog Number
SCVW104
Brand Name
SemperCare Stretch Vinyl Walleted Exam Glove
Version/Model Number
SCVW104
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
LYZ
Product Code Name
Vinyl Patient Examination Glove
Public Device Record Key
26272e8e-13fe-49ca-873f-a780ddeb5b5b
Public Version Date
May 09, 2022
Public Version Number
1
DI Record Publish Date
April 30, 2022
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 |