Catalog Number

-

Brand Name

huayuan

Version/Model Number

Nitrile

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

February 14, 2027

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

K211727

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

a455c026-4f39-483e-b2af-1febb0ea2c07

Public Version Date

February 22, 2022

Public Version Number

1

DI Record Publish Date

February 14, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-