Duns Number:961027315
Device Description: Synthetic with Neu-Thera® Powder-Free Vinyl Exam Gloves Stretchy Protects Restores Moistur Synthetic with Neu-Thera® Powder-Free Vinyl Exam Gloves Stretchy Protects Restores Moisturizes
Catalog Number
S88RX01
Brand Name
ESTEEM
Version/Model Number
S88RX01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2020
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
-
Product Code
LYZ
Product Code Name
Vinyl patient examination glove
Public Device Record Key
c9a42f30-6b95-46d5-b4a0-46bc2abf418e
Public Version Date
January 11, 2021
Public Version Number
5
DI Record Publish Date
January 02, 2019
Package DI Number
50885380135390
Quantity per Package
10
Contains DI Package
20885380135399
Package Discontinue Date
December 31, 2020
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 |