Duns Number:961027315
Device Description: Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating
Catalog Number
2D73DP80
Brand Name
PROTEXIS
Version/Model Number
2D73DP80
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"
Yes
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
KGO
Product Code Name
Surgeon's gloves
Public Device Record Key
a412c9aa-ce79-466a-8294-a40bf2de3cd6
Public Version Date
July 23, 2018
Public Version Number
2
DI Record Publish Date
April 13, 2018
Package DI Number
50885380024588
Quantity per Package
4
Contains DI Package
20885380024587
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |