Catalog Number

5412077

Brand Name

LEADER

Version/Model Number

5412077

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

K093375,K093375,K093375

Product Code

LYY

Product Code Name

Latex patient examination glove

Public Device Record Key

432cdb78-8d6b-4f37-8e64-0000d423e1cc

Public Version Date

July 02, 2021

Public Version Number

3

DI Record Publish Date

September 23, 2018

Package DI Number

50096295133344

Quantity per Package

10

Contains DI Package

00096295133349

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE