Catalog Number

-

Brand Name

JIANGXI ZHONGHONG PULIN

Version/Model Number

S/M/L/XL

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

K182117

Product Code

LYZ

Product Code Name

Vinyl Patient Examination Glove

Public Device Record Key

6cd35389-f9d3-47fd-b4d6-101e724f17ee

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

February 20, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-