Duns Number:830997032
Device Description: Examination Gloves
Catalog Number
53141-54
Brand Name
KIMTECH STERLING NITRILE XTRA EXAM GLOVES (XL)
Version/Model Number
53141
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 15, 2020
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
K081089,K081089,K081089
Product Code
LZC
Product Code Name
Patient examination glove, specialty
Public Device Record Key
4fb5444c-22f2-4a8a-a6d2-442ca3794aec
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
March 13, 2020
Package DI Number
10036026531416
Quantity per Package
10
Contains DI Package
00036026531419
Package Discontinue Date
April 15, 2020
Package Status
Not 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 |