Duns Number:039612668
Device Description: Size Large
Catalog Number
-
Brand Name
Ext Cuff 12 MIL Latex Gloves-L
Version/Model Number
S-17904L
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 29, 2020
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
K982877,K982877,K982877
Product Code
LYY
Product Code Name
Latex Patient Examination Glove
Public Device Record Key
e0627b85-0232-428b-a408-02dc0d8777fd
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
April 14, 2020
Package DI Number
30851253007923
Quantity per Package
10
Contains DI Package
10851253007929
Package Discontinue Date
April 29, 2020
Package Status
Not 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 |