Duns Number:830997032
Device Description: Examination Gloves
Catalog Number
50705-54
Brand Name
KIMTECH STERLING NITRILE EXAM GLOVES (XS)
Version/Model Number
50705
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
K161215,K161215,K161215
Product Code
LZC
Product Code Name
Patient examination glove, specialty
Public Device Record Key
7239eaed-7eae-45de-9d45-4e2b8741c6c1
Public Version Date
September 10, 2020
Public Version Number
3
DI Record Publish Date
March 23, 2020
Package DI Number
10036000507055
Quantity per Package
10
Contains DI Package
00036000507058
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 |