Catalog Number

52819-54

Brand Name

KIMTECH LAVENDER NITRILE EXAM GLOVES (L)

Version/Model Number

52819

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 15, 2020

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"

-

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

-

Product Code

LZA

Product Code Name

Polymer patient examination glove

Public Device Record Key

4b8c6e5d-f071-4773-8e6b-121b241972ef

Public Version Date

November 15, 2021

Public Version Number

4

DI Record Publish Date

March 13, 2020

Package DI Number

10036003528194

Quantity per Package

10

Contains DI Package

00036003528197

Package Discontinue Date

April 15, 2020

Package Status

Not in Commercial Distribution

Package Type

Case