Duns Number:961027315
Device Description: Nitrile Exam Gloves
Catalog Number
8899EC
Brand Name
ESTEEM
Version/Model Number
8899EC
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K183354,K183354,K183354
Product Code
LZA
Product Code Name
Polymer patient examination glove
Public Device Record Key
ed2e8fce-ad33-4e97-a5a3-367e8853f11c
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
May 07, 2020
Package DI Number
50885380174306
Quantity per Package
10
Contains DI Package
20885380174305
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
EACH
| 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 |