Duns Number:961027315
Device Description: Sterile Synthetic Polyisoprene Powder-Free Surgical Gloves with Hydrogel Coating, Smooth F Sterile Synthetic Polyisoprene Powder-Free Surgical Gloves with Hydrogel Coating, Smooth Finish, Straight Finger
Catalog Number
2D73HT65
Brand Name
PROTEXIS
Version/Model Number
2D73HT65
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
15a54e1f-83bd-43a5-b881-7bacb8bc3720
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
May 01, 2018
Package DI Number
50885380125933
Quantity per Package
4
Contains DI Package
20885380125932
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 |