Duns Number:012430880
Device Description: Elastex PF Nitrile Glove MEDIUM
Catalog Number
1033301
Brand Name
Elastex PF Nitrile Glove
Version/Model Number
1033301
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
1423aa14-d732-427a-858c-ff7b94cbc184
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
January 08, 2020
Package DI Number
10304040056971
Quantity per Package
10
Contains DI Package
00304040056974
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 |