Duns Number:112042723
Device Description: SHADOW® Disposable Nitrile Exam Gloves, Powder Free, Black, 6 mil, Ex-Small, 100/bx, 10 bx SHADOW® Disposable Nitrile Exam Gloves, Powder Free, Black, 6 mil, Ex-Small, 100/bx, 10 bxs/cs
Catalog Number
SHD930
Brand Name
Shadow
Version/Model Number
SHD930
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)
Yes
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
36bb28da-bd49-4137-bd7c-4db6584dfe59
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
April 20, 2020
Package DI Number
06531953293040
Quantity per Package
10
Contains DI Package
00653195329304
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box