Duns Number:072943876
Device Description: Powder-Free Vinyl Gloves, 100 gloves per box (by weight)
Catalog Number
-
Brand Name
TopCare health
Version/Model Number
036800436480
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 26, 2022
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
597c51da-0134-443b-a7a6-4de267ff7946
Public Version Date
August 03, 2022
Public Version Number
2
DI Record Publish Date
August 03, 2020
Package DI Number
10036800436487
Quantity per Package
6
Contains DI Package
00036800436480
Package Discontinue Date
April 26, 2022
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 1 |