Duns Number:012430880
Device Description: CRITERION NITRILE EC GLOV
Catalog Number
1126788
Brand Name
Henry Schein
Version/Model Number
1126788
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
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
-
Product Code
LZA
Product Code Name
Polymer patient examination glove
Public Device Record Key
d6665d3d-4dc9-466f-886d-0d413ef56c8c
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
May 15, 2020
Package DI Number
H65811267882
Quantity per Package
10
Contains DI Package
H65811267881
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 | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |