Duns Number:686206908
Device Description: S1 Nitrile Exam Gloves, Size L
Catalog Number
-
Brand Name
Toptolife
Version/Model Number
14140007
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
d305a000-e299-4722-944b-0c7b28493031
Public Version Date
March 10, 2022
Public Version Number
1
DI Record Publish Date
March 02, 2022
Package DI Number
24897115200117
Quantity per Package
10
Contains DI Package
14897115200110
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton