Catalog Number

52817-54

Brand Name

KIMTECH LAVENDER NITRILE EXAM GLOVES (S)

Version/Model Number

52817

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

adf41b92-6b0a-4261-8164-1686927f2ef0

Public Version Date

November 15, 2021

Public Version Number

4

DI Record Publish Date

March 13, 2020

Package DI Number

10036005528178

Quantity per Package

10

Contains DI Package

00036005528171

Package Discontinue Date

April 15, 2020

Package Status

Not in Commercial Distribution

Package Type

Case