Catalog Number

-

Brand Name

Lydus

Version/Model Number

LY2100NPFNS2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

September 26, 2024

Issuing Agency

In HIBCC

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

K203191,K203191

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

8e6313d0-0ac0-4138-b7e6-a85e8f9211de

Public Version Date

March 07, 2022

Public Version Number

1

DI Record Publish Date

February 27, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-