Duns Number:007900020
Device Description: ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Black, 5 mil, Large, 100/bx, ProWorks® Disposable Nitrile Exam Grade Gloves, Powder Free, Black, 5 mil, Large, 100/bx, 10 bxs/cs
Catalog Number
GL-N145FL
Brand Name
ProWork
Version/Model Number
GL-N145FL
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
00a364b9-d088-41be-af2c-42dba73805db
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
April 02, 2020
Package DI Number
10075289145039
Quantity per Package
10
Contains DI Package
00075289145032
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |