Catalog Number

5412184

Brand Name

LEADER

Version/Model Number

5412184

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LZA

Product Code Name

Polymer patient examination glove

Public Device Record Key

f5b70c9d-b867-4069-b169-716978b8bacf

Public Version Date

July 02, 2021

Public Version Number

3

DI Record Publish Date

September 24, 2018

Package DI Number

50096295133443

Quantity per Package

10

Contains DI Package

00096295133448

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE