Duns Number:012430880
Device Description: Elastex PF Nitrile Glove LARGE
Catalog Number
1033341
Brand Name
Elastex PF Nitrile Glove
Version/Model Number
1033341
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"
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
K152937,K152937,K152937
Product Code
LZA
Product Code Name
Polymer patient examination glove
Public Device Record Key
823d1ba8-8bb7-4cc3-b66d-0884733cbcc8
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
January 08, 2020
Package DI Number
10304040056964
Quantity per Package
10
Contains DI Package
00304040056967
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 |