Duns Number:421347466
Device Description: A non-sterile device made of Nitrile intended as a protective barrier when worn on the han A non-sterile device made of Nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes.
Catalog Number
-
Brand Name
Annuy Powder-free Nitrile Patient Examination Glove
Version/Model Number
L
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
K150612,K150612
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
6a693a32-f408-4205-8e02-9bdb7f889140
Public Version Date
February 03, 2021
Public Version Number
1
DI Record Publish Date
January 26, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |