Duns Number:961027315
Device Description: Sterile Latex Powder-Free Surgical Gloves with Hydrogel Coating, Smooth Finish, Straight F Sterile Latex Powder-Free Surgical Gloves with Hydrogel Coating, Smooth Finish, Straight Finger
Catalog Number
2D72LT65
Brand Name
PROTEXIS
Version/Model Number
2D72LT65
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)
Yes
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
KGO
Product Code Name
Surgeon's gloves
Public Device Record Key
ef294a9c-d2fa-4d77-bfac-b37f1b9f0077
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
May 02, 2018
Package DI Number
50885380118928
Quantity per Package
4
Contains DI Package
20885380118927
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 |