Duns Number:008124539
Device Description: Safe-Touch Vinyl Examination Gloves, Powder-Free, Ambidextrous, Medium
Catalog Number
-
Brand Name
Safe-Touch Vinyl Examination Gloves, Powder-Free
Version/Model Number
2612
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)
-
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
K100339,K131832,K100339,K131832,K100339,K131832
Product Code
LYZ
Product Code Name
Vinyl Patient Examination Glove
Public Device Record Key
0b10b3cd-8155-400a-bc0d-289206fa1a58
Public Version Date
May 02, 2022
Public Version Number
1
DI Record Publish Date
April 23, 2022
Package DI Number
00616784261232
Quantity per Package
10
Contains DI Package
00616784261225
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 |