Duns Number:013112308
Device Description: LATEX POLYMER POWDER FREE SURGICAL GLOVES (PALM TEXTURE) SIZE 6.5, PAIR
Catalog Number
SG805065
Brand Name
Rospital Productos Medicos
Version/Model Number
SG805065
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)
-
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
05ebaa5d-a6d8-4801-9a40-ec48e4f5b916
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
May 02, 2020
Package DI Number
10812460026684
Quantity per Package
50
Contains DI Package
00812460026687
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |