Catalog Number

5412101

Brand Name

LEADER

Version/Model Number

5412101

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

K062522,K062522,K062522

Product Code

LYZ

Product Code Name

Vinyl patient examination glove

Public Device Record Key

3dc353bf-31d6-4177-b9c4-f83bae81fd4e

Public Version Date

July 02, 2021

Public Version Number

2

DI Record Publish Date

September 23, 2018

Package DI Number

50096295133375

Quantity per Package

10

Contains DI Package

00096295133370

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE