Duns Number:012430880
Device Description: Criterion N300 Powder-Free Nitrile Examination Gloves X-LARGE
Catalog Number
1126833
Brand Name
Henry Schein
Version/Model Number
1126833
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
K143247,K143247,K143247
Product Code
LZA
Product Code Name
Polymer patient examination glove
Public Device Record Key
d5aa8019-f461-412f-96c4-63778804b54a
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
March 04, 2019
Package DI Number
20304040102576
Quantity per Package
10
Contains DI Package
10304040102579
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 |