Duns Number:830997032
Device Description: Examination Gloves
Catalog Number
53104-54
Brand Name
KIMTECH TEXTURED BLUE NITRILE EXAM GLOVES (XL)
Version/Model Number
53104
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"
-
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
K962139,K962139,K962139
Product Code
LZA
Product Code Name
Polymer patient examination glove
Public Device Record Key
8da2f2eb-3b36-4e5e-a789-bef62542b824
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
March 13, 2020
Package DI Number
10036000531043
Quantity per Package
10
Contains DI Package
00036000531046
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 | 1 |