Duns Number:039612668
Device Description: Size Medium Gloves
Catalog Number
S-19177M
Brand Name
Toughgrip 7 Mil Latex Gloves - M
Version/Model Number
S-19177M
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
K953590,K953590,K953590
Product Code
LYY
Product Code Name
Latex Patient Examination Glove
Public Device Record Key
5a684eda-9f26-4209-ade0-691d10ebd8e3
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
December 12, 2018
Package DI Number
30851253007251
Quantity per Package
10
Contains DI Package
10851253007257
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 |