Catalog Number

-

Brand Name

huayuan

Version/Model Number

Nitrile

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

August 19, 2026

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

K131823

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

0eacb28d-abcc-4d67-ad5f-abd61a4dfee6

Public Version Date

August 27, 2021

Public Version Number

1

DI Record Publish Date

August 19, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-