Duns Number:008124539
Device Description: Next Generation Stretch Vinyl Exam Gloves, Powder-Free, Medium
Catalog Number
-
Brand Name
Next Generation Stretch Vinyl Exam Gloves
Version/Model Number
6823
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
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
K100486,K100486,K100486
Product Code
LYZ
Product Code Name
Vinyl Patient Examination Glove
Public Device Record Key
88da8f01-7ce7-47c3-9895-2ed9d7ab5713
Public Version Date
May 31, 2021
Public Version Number
1
DI Record Publish Date
May 21, 2021
Package DI Number
00709553682335
Quantity per Package
10
Contains DI Package
00709553682328
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |