Duns Number:073477685
Device Description: Schneider Disposable Powder-Free Vinyl Synthetic Exam Gloves, Blue, VSFB3001, 100ct Box, S Schneider Disposable Powder-Free Vinyl Synthetic Exam Gloves, Blue, VSFB3001, 100ct Box, Size Small
Catalog Number
-
Brand Name
Schneider
Version/Model Number
VSFB3001
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
K112266,K112266
Product Code
LYZ
Product Code Name
Vinyl Patient Examination Glove
Public Device Record Key
ec29e66c-2d85-4704-a135-139d93519849
Public Version Date
October 31, 2022
Public Version Number
3
DI Record Publish Date
October 09, 2022
Package DI Number
00810112471151
Quantity per Package
10
Contains DI Package
00850028934265
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 | 6 |