Duns Number:080061451
Device Description: Disposable Nitrile Gloves Class 400 - Size LargeHEPRO.US Nitrile Disposable Gloves Deluxe Disposable Nitrile Gloves Class 400 - Size LargeHEPRO.US Nitrile Disposable Gloves Deluxe Class 400 Blue 9" Non-Powdered Textured 1 Box of 100pcs- 10 Boxes per Case
Catalog Number
-
Brand Name
HEPRO.US Disposable Nitrile Gloves Class 400 - Size Large
Version/Model Number
CT - 400 Nitrile Large
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
-
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
cd874f7f-3f33-4295-90f5-8a3e101bbe43
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
June 21, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |