Duns Number:017524666
Device Description: SUPERFIT Disposable Latex Surgical Gloves. Powder Free. Size 6.0.
Catalog Number
-
Brand Name
SUPERFIT
Version/Model Number
A520-LTX60
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
K063757,K063757,K063757
Product Code
KGO
Product Code Name
Surgeon'S Gloves
Public Device Record Key
6f06ef24-0be4-4ed5-8814-6d4252b67ed6
Public Version Date
August 14, 2020
Public Version Number
1
DI Record Publish Date
August 06, 2020
Package DI Number
10814639023371
Quantity per Package
50
Contains DI Package
00814639023374
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 121 |