Duns Number:961027315
Device Description: Fingertip Textured Esteem Stretchy Nitrile Powder-Free Nitrile Exam Gloves
Catalog Number
8815NB
Brand Name
ESTEEM
Version/Model Number
8815NB
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 08, 2019
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K110960,K110960,K110960
Product Code
LZA
Product Code Name
Polymer patient examination glove
Public Device Record Key
93db28cc-8caa-4724-8f9b-b3af770d0dcf
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
January 30, 2019
Package DI Number
50885380137165
Quantity per Package
10
Contains DI Package
20885380137164
Package Discontinue Date
March 08, 2019
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |