Duns Number:008124539
Device Description: Safe-Touch Blue Nitrile Examination Gloves, Powder Free, Large, Ambidextrous
Catalog Number
-
Brand Name
Safe-Touch Blue Nitrile Examination Gloves
Version/Model Number
2513
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
K152720,K152720,K152720
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
3b0c3e77-4c67-4a4d-847f-ed1c91c82930
Public Version Date
May 02, 2022
Public Version Number
1
DI Record Publish Date
April 22, 2022
Package DI Number
00616784251332
Quantity per Package
10
Contains DI Package
00616784251325
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 |