Duns Number:543265548
Device Description: Extra large size
Catalog Number
-
Brand Name
KINGFA MEDICAL
Version/Model Number
KG-1101
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K203593,K203593,K203593
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
6ae05eb0-fa2c-42aa-bdd8-05ea264789ba
Public Version Date
May 18, 2021
Public Version Number
1
DI Record Publish Date
May 10, 2021
Package DI Number
26973163402968
Quantity per Package
10
Contains DI Package
16973163402961
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |