Duns Number:039612668
Device Description: Sub Item Number
Catalog Number
-
Brand Name
EXT Cuff 12 Mil Latex Gloves-L
Version/Model Number
S-17904L-S1
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
K123819,K123819,K123819
Product Code
LYY
Product Code Name
Latex Patient Examination Glove
Public Device Record Key
e0105969-7731-411c-a127-7ebb6eac8d79
Public Version Date
December 31, 2020
Public Version Number
1
DI Record Publish Date
December 23, 2020
Package DI Number
30850015055066
Quantity per Package
10
Contains DI Package
10850015055109
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 2 |