Duns Number:023904428
Device Description: PF BLACK NITRILE EXAM GLOVE, M
Catalog Number
-
Brand Name
Cypress
Version/Model Number
27-74
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 04, 2022
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
7ad5435f-fa86-4d55-b909-77b357b1664f
Public Version Date
February 07, 2022
Public Version Number
3
DI Record Publish Date
May 22, 2020
Package DI Number
00815555025091
Quantity per Package
10
Contains DI Package
00815555025084
Package Discontinue Date
February 04, 2022
Package Status
Not in Commercial Distribution
Package Type
10
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |