Catalog Number

-

Brand Name

KINGFA MEDICAL

Version/Model Number

KG-1601

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

2c77fe55-511a-4f67-8e70-513397808957

Public Version Date

May 18, 2021

Public Version Number

1

DI Record Publish Date

May 10, 2021

Package DI Number

26973163403224

Quantity per Package

10

Contains DI Package

16973163403227

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton